K760307 is an FDA 510(k) clearance for the BEDPAN, SINGLE PATIENT USE, TECNOL. This device is classified as a Bedpan (Class I - General Controls, product code FOB).
Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on August 11, 1976, 16 days after receiving the submission on July 26, 1976.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6730.
| 510(k) Number | K760307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1976 |
| Decision Date | August 11, 1976 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FOB — Bedpan |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6730 |