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 |