K760850 is an FDA 510(k) clearance for the PARKES HUMP GAUGE STRAIGHT 7 (18 CM). This device is classified as a Gouge, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDH).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1976, 19 days after receiving the submission on October 15, 1976.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K760850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1976 |
| Decision Date | November 03, 1976 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDH — Gouge, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |