The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial.
| Device ID | K890707 |
| 510k Number | K890707 |
| Device Name: | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Van Hof |
| Correspondent | Van Hof DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-10 |
| Decision Date | 1989-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994844884 | K890707 | 000 |
| 20613994844877 | K890707 | 000 |