K240438 is an FDA 510(k) clearance for the CDB Hospital ® Sterilization Wrap (70 gsm). This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Comercializadora Brever (Leon, MX). The FDA issued a Cleared decision on November 4, 2024, 264 days after receiving the submission on February 14, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K240438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2024 |
| Decision Date | November 04, 2024 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |