K953678 is an FDA 510(k) clearance for the STERIMED STERIZATION WRAPPER (NON-STERILE). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on October 2, 1995, 56 days after receiving the submission on August 7, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K953678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1995 |
| Decision Date | October 02, 1995 |
| Days to Decision | 56 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 |