The following data is part of a premarket notification filed by Bernard J. Cooney, P.a. with the FDA for Amukin 50% - Airspray(r).
| Device ID | K885037 |
| 510k Number | K885037 |
| Device Name: | AMUKIN 50% - AIRSPRAY(R) |
| Classification | Catheter, Peritoneal Dialysis, Single Use |
| Applicant | BERNARD J. COONEY, P.A. 2 WISCONSIN CIRCLE SUITE 706 Chevy Chase, MD 20815 |
| Contact | Joanne Ogilvie |
| Correspondent | Joanne Ogilvie BERNARD J. COONEY, P.A. 2 WISCONSIN CIRCLE SUITE 706 Chevy Chase, MD 20815 |
| Product Code | FKO |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1990-10-19 |