The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Apiration Biopsy Syringe Gun, Cat. Code #54501.
| Device ID | K913098 |
| 510k Number | K913098 |
| Device Name: | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 |
| Classification | Instrument, Biopsy |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1991-11-05 |