K872823 is an FDA 510(k) clearance for the DELTA SCRUB. This device is classified as a Brush, Scrub, Operating-room (Class I - General Controls, product code GEC).
Submitted by Pacific Biosystems, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 7, 1988, 175 days after receiving the submission on July 16, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K872823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1987 |
| Decision Date | January 07, 1988 |
| Days to Decision | 175 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 |