The following data is part of a premarket notification filed by Advanced Diagnostic Medical Systems, Inc. with the FDA for Adms Silent Needle Gun.
| Device ID | K882746 |
| 510k Number | K882746 |
| Device Name: | ADMS SILENT NEEDLE GUN |
| Classification | Instrument, Biopsy |
| Applicant | ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Contact | Gary J Allsebrook |
| Correspondent | Gary J Allsebrook ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-05 |
| Decision Date | 1989-03-17 |