Submission Details
| 510(k) Number | K885037 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 05, 1988 |
| Decision Date | October 19, 1990 |
| Days to Decision | 683 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
AMUKIN 50% - AIRSPRAY(R)
Oct 1990
Decision
683d
Days
Class 2
Risk
About This 510(k) Submission
K885037 is an FDA 510(k) clearance for the AMUKIN 50% - AIRSPRAY(R), a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Bernard J. Cooney, P.A. (Chevy Chase, US). The FDA issued a Cleared decision on October 19, 1990, 683 days after receiving the submission on December 5, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
Device Classification
| Product Code | FKO — Catheter, Peritoneal Dialysis, Single Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |
Manufacturer
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