The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Coronary Ostium Occluder, Catalog Code 32015.
Device ID | K880860 |
510k Number | K880860 |
Device Name: | CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 |
Classification | Occluder, Catheter Tip |
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 | DQT |
CFR Regulation Number | 870.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-05-26 |