The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Reusable Mlyocardial Biopsy Forceps (bioptomes.
| Device ID | K890453 |
| 510k Number | K890453 |
| Device Name: | REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Contact | Van Hof |
| Correspondent | Van Hof DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-03-31 |