The following data is part of a premarket notification filed by Vibronics with the FDA for Vibronics Auto Core Biopsy Device (acbd).
| Device ID | K904987 |
| 510k Number | K904987 |
| Device Name: | VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) |
| Classification | Instrument, Biopsy |
| Applicant | VIBRONICS 401 SOUTH HARTZ AVE. SUITE 301 Danville, CA 94526 |
| Contact | Richard Terwilliger |
| Correspondent | Richard Terwilliger VIBRONICS 401 SOUTH HARTZ AVE. SUITE 301 Danville, CA 94526 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333004380 | K904987 | 000 |
| 20886333224078 | K904987 | 000 |
| 20886333224085 | K904987 | 000 |
| 20886333224092 | K904987 | 000 |
| 20886333224009 | K904987 | 000 |
| 20886333224016 | K904987 | 000 |
| 20886333224023 | K904987 | 000 |
| 20886333224030 | K904987 | 000 |
| 20886333224047 | K904987 | 000 |
| 20886333224054 | K904987 | 000 |
| 20886333004342 | K904987 | 000 |
| 20886333004359 | K904987 | 000 |
| 20886333004366 | K904987 | 000 |
| 20886333004373 | K904987 | 000 |
| 20886333224061 | K904987 | 000 |