K900691 is an FDA 510(k) clearance for the BIODYNE INSTRUMENT WIPES. This device is classified as a Brush, Scrub, Operating-room (Class I - General Controls, product code GEC).
Submitted by Bio-Dyne, Inc. (La Mesa, US). The FDA issued a Cleared decision on March 8, 1990, 23 days after receiving the submission on February 13, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K900691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1990 |
| Decision Date | March 08, 1990 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEC — Brush, Scrub, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |