K915303 is an FDA 510(k) clearance for the FOIL BABY BUNTING. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on February 20, 1992, 91 days after receiving the submission on November 21, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K915303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1991 |
| Decision Date | February 20, 1992 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |