K801326 is an FDA 510(k) clearance for the ANSPACH OPERATING TABLE SUPPORT/SPINAL. This device is classified as a Support, Head, Surgical, Ent (Class I - General Controls, product code EPW).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980, 23 days after receiving the submission on June 3, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K801326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1980 |
| Decision Date | June 26, 1980 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EPW — Support, Head, Surgical, Ent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |