K760662 is an FDA 510(k) clearance for the STERIL.WRAP(#221901,2,3,4,5,6,7,8,9). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976, 104 days after receiving the submission on September 17, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K760662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1976 |
| Decision Date | December 30, 1976 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |