The following data is part of a premarket notification filed by Angiomed Gmbh & Co. Medizintechnik Kg with the FDA for Auto-vac Biopsy Needle.
| Device ID | K912892 |
| 510k Number | K912892 |
| Device Name: | AUTO-VAC BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG WACHHAUSSTR. 6 D-W 7500 KARLSRUHE 41 Germany, DE |
| Contact | Dr. F Theesen |
| Correspondent | Dr. F Theesen ANGIOMED GMBH & CO. MEDIZINTECHNIK KG WACHHAUSSTR. 6 D-W 7500 KARLSRUHE 41 Germany, DE |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1992-02-07 |