K851340 is an FDA 510(k) clearance for the BLUE SEAL II STERILIZATION POUCH. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on April 24, 1985, 21 days after receiving the submission on April 3, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K851340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1985 |
| Decision Date | April 24, 1985 |
| Days to Decision | 21 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 |