The following data is part of a premarket notification filed by Dianon Systems, Inc. with the FDA for Code #d2020-fine Needle Aspiration Biopsy System.
| Device ID | K882105 |
| 510k Number | K882105 |
| Device Name: | CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | DIANON SYSTEMS, INC. 200 WATSON BLVD. Stratford, CT 06497 |
| Contact | Phillenore Howard |
| Correspondent | Phillenore Howard DIANON SYSTEMS, INC. 200 WATSON BLVD. Stratford, CT 06497 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-07-11 |