The following data is part of a premarket notification filed by V. Mueller O.v. Baxter Healthcare Corp. with the FDA for Parkes Hump Gauge Straight 7 (18 Cm).
| Device ID | K760850 |
| 510k Number | K760850 |
| Device Name: | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) |
| Classification | Gouge, Surgical, General & Plastic Surgery |
| Applicant | V. MUELLER O.V. BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-15 |
| Decision Date | 1976-11-03 |