K960621 is an FDA 510(k) clearance for the EXPANDACELL INSTRUMENT WIPE. This device is classified as a Brush, Scrub, Operating-room (Class I - General Controls, product code GEC).
Submitted by Shippert Medical Technologies Corp. (Englewood, US). The FDA issued a Cleared decision on April 1, 1996, 48 days after receiving the submission on February 13, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K960621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1996 |
| Decision Date | April 01, 1996 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEC — Brush, Scrub, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |