The following data is part of a premarket notification filed by National-standard Co. with the FDA for Automated Disposable Soft Tissue Biopsy Cutting.
| Device ID | K895885 |
| 510k Number | K895885 |
| Device Name: | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING |
| Classification | Punch, Biopsy |
| Applicant | NATIONAL-STANDARD CO. 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Contact | Robinson |
| Correspondent | Robinson NATIONAL-STANDARD CO. 4445-360 S.W. 35TH TERRACE Gainesville, FL 32608 |
| Product Code | FCI |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1990-02-09 |