The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Hot Biopsy Forceps W/round Cups.
| Device ID | K820983 |
| 510k Number | K820983 |
| Device Name: | HOT BIOPSY FORCEPS W/ROUND CUPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MILL-ROSE LABORATORY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-06 |
| Decision Date | 1982-04-26 |