K971473 is an FDA 510(k) clearance for the IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK. This device is classified as a Brush, Scrub, Operating-room (Class I - General Controls, product code GEC).
Submitted by M-Pact Worldwide Management Corp. (Eudora, US). The FDA issued a Cleared decision on July 7, 1997, 75 days after receiving the submission on April 23, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K971473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1997 |
| Decision Date | July 07, 1997 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEC — Brush, Scrub, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |