K030853 is an FDA 510(k) clearance for the STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Case Medical, Inc. (Ridgefield, US). The FDA issued a Cleared decision on March 21, 2003, 3 days after receiving the submission on March 18, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K030853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2003 |
| Decision Date | March 21, 2003 |
| Days to Decision | 3 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 |