The following data is part of a premarket notification filed by Dianon Systems, Inc. with the FDA for Fine Needle Aspiration Biopsy System-prostate.
| Device ID | K872597 |
| 510k Number | K872597 |
| Device Name: | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | DIANON SYSTEMS, INC. 200 WATSON BLVD. Stratford, CT 06497 |
| Contact | Foemmel, Phd |
| Correspondent | Foemmel, Phd DIANON SYSTEMS, INC. 200 WATSON BLVD. Stratford, CT 06497 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-02 |
| Decision Date | 1987-07-28 |