The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Cardioplegia Delivery Sets.
Device ID | K892368 |
510k Number | K892368 |
Device Name: | RMI CARDIOPLEGIA DELIVERY SETS |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
Contact | Michael N Kelly |
Correspondent | Michael N Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-06 |
Decision Date | 1989-12-07 |