The following data is part of a premarket notification filed by Advanced Biomedical Instruments with the FDA for Biopser.
| Device ID | K820519 |
| 510k Number | K820519 |
| Device Name: | BIOPSER |
| Classification | Forceps, Biopsy, Gynecological |
| Applicant | ADVANCED BIOMEDICAL INSTRUMENTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HFB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-25 |
| Decision Date | 1982-04-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOPSER 73321639 1213168 Dead/Cancelled |
Metallisations et Traitements Optiques M.T.O. 1981-07-31 |