K955661 is an FDA 510(k) clearance for the ACU-HALT, submitted by Glederer & Co., Inc. (Paterson, US). The FDA issued a Cleared decision on December 30, 1996, 384 days after receiving the submission on December 12, 1995. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K955661 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 12, 1995 |
| Decision Date | December 30, 1996 |
| Days to Decision | 384 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LDQ |
| Device Class | — |