K945004 is an FDA 510(k) clearance for the 2, 3 & 4 BANDADGE COMPRESS. This device is classified as a Gauze/sponge, Internal.
Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 22, 1995, 160 days after receiving the submission on October 13, 1994.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K945004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1994 |
| Decision Date | March 22, 1995 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EFQ — Gauze/sponge, Internal |
| Device Class | — |