The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Douglas Medical Products, Inc. Irrigation Set.
| Device ID | K922318 |
| 510k Number | K922318 |
| Device Name: | DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET |
| Classification | Arthroscope |
| Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
| Contact | Douglas Johnson |
| Correspondent | Douglas Johnson DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-18 |
| Decision Date | 1992-08-10 |