K810303 is an FDA 510(k) clearance for the TELEVISION CAMERA HOLDER FOR SURGERY. This device is classified as a Holder, Camera, Surgical (Class I - General Controls, product code FXR).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981, 21 days after receiving the submission on February 5, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K810303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1981 |
| Decision Date | February 26, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FXR — Holder, Camera, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |