The following data is part of a premarket notification filed by Advanced Diagnostic Medical Systems, Inc. with the FDA for Biopsy Attach. For Adms Ultrasound Probe.
| Device ID | K875119 |
| 510k Number | K875119 |
| Device Name: | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE |
| Classification | Punch, Biopsy |
| Applicant | ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Contact | J Allsebrook |
| Correspondent | J Allsebrook ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Product Code | FCI |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-03-02 |