The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Hsw Gmbh Arthroscope.
| Device ID | K962075 |
| 510k Number | K962075 |
| Device Name: | HSW GMBH ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550 |
| Contact | John M Smith |
| Correspondent | John M Smith HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge, MA 01550 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1997-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854044206 | K962075 | 000 |
| 30845854031821 | K962075 | 000 |
| 30845854031838 | K962075 | 000 |
| 30845854031845 | K962075 | 000 |
| 30845854031852 | K962075 | 000 |
| 30845854031869 | K962075 | 000 |
| 30845854031876 | K962075 | 000 |
| 30845854031883 | K962075 | 000 |
| 30845854031890 | K962075 | 000 |
| 30845854031814 | K962075 | 000 |
| 30845854031791 | K962075 | 000 |
| 30845854012851 | K962075 | 000 |
| 30845854012998 | K962075 | 000 |
| 30845854013131 | K962075 | 000 |
| 30845854027107 | K962075 | 000 |
| 30845854027114 | K962075 | 000 |
| 30845854028821 | K962075 | 000 |
| 30845854031777 | K962075 | 000 |
| 30845854031784 | K962075 | 000 |
| 30845854031906 | K962075 | 000 |
| 30845854031913 | K962075 | 000 |
| 30845854031920 | K962075 | 000 |
| 30845854040441 | K962075 | 000 |
| 30845854040502 | K962075 | 000 |
| 30845854040557 | K962075 | 000 |
| 30845854040564 | K962075 | 000 |
| 30845854080577 | K962075 | 000 |
| 30845854605749 | K962075 | 000 |
| 30845854605756 | K962075 | 000 |
| 30845854605763 | K962075 | 000 |
| 30845854036413 | K962075 | 000 |
| 30845854036406 | K962075 | 000 |
| 30845854032026 | K962075 | 000 |
| 30845854032064 | K962075 | 000 |
| 30845854032705 | K962075 | 000 |
| 30845854035973 | K962075 | 000 |
| 30845854035980 | K962075 | 000 |
| 30845854035997 | K962075 | 000 |
| 30845854036000 | K962075 | 000 |
| 30845854036017 | K962075 | 000 |
| 30845854605770 | K962075 | 000 |