The following data is part of a premarket notification filed by August C. Stiefel Research Institute, Inc. with the FDA for Disposable, Sterile Biopsy Punch.
| Device ID | K853104 |
| 510k Number | K853104 |
| Device Name: | DISPOSABLE, STERILE BIOPSY PUNCH |
| Classification | Punch, Biopsy |
| Applicant | AUGUST C. STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | William A Carr |
| Correspondent | William A Carr AUGUST C. STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Product Code | FCI |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-10-04 |