The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Biopsy Attachment.
| Device ID | K831317 |
| 510k Number | K831317 |
| Device Name: | BIOPSY ATTACHMENT |
| Classification | Punch, Biopsy |
| Applicant | DIASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCI |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-22 |
| Decision Date | 1983-05-18 |