K002968 is an FDA 510(k) clearance for the MEDLINE STERILIZATION WRAP. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 23, 2001, 123 days after receiving the submission on September 22, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K002968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2000 |
| Decision Date | January 23, 2001 |
| Days to Decision | 123 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 |