K935622 is an FDA 510(k) clearance for the CUSTOM PLASTIC PACKS. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Associated Medical (Minnetonka, US). The FDA issued a Cleared decision on February 7, 1994, 77 days after receiving the submission on November 22, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K935622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1993 |
| Decision Date | February 07, 1994 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |