The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Drill Bit And Drill Guide.
| Device ID | K944590 |
| 510k Number | K944590 |
| Device Name: | ETHICON DRILL BIT AND DRILL GUIDE |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | John D Paulson |
| Correspondent | John D Paulson ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1995-05-11 |