K013003 is an FDA 510(k) clearance for the APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on August 28, 2002, 356 days after receiving the submission on September 6, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K013003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2001 |
| Decision Date | August 28, 2002 |
| Days to Decision | 356 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 |