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 |