K914081 is an FDA 510(k) clearance for the ICAN COTTON RAYON BALLS. This device is classified as a Fiber, Medical, Absorbent (Class I - General Controls, product code FRL).
Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 9, 1991, 28 days after receiving the submission on September 11, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5300.
| 510(k) Number | K914081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1991 |
| Decision Date | October 09, 1991 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRL — Fiber, Medical, Absorbent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5300 |