Submission Details
| 510(k) Number | K821293 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K821293 is an FDA 510(k) clearance for the BACKHAUS CLAMP, 5 1/4. This device is classified as a Forceps (Class I — General Controls, product code HTD).
Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 24 days after receiving the submission on May 4, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K821293 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTD — Forceps |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |