The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi External Coronary Artery Occluder.
Device ID | K920936 |
510k Number | K920936 |
Device Name: | RMI EXTERNAL CORONARY ARTERY OCCLUDER |
Classification | Clamp, Vascular |
Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | Rd Hibbert |
Correspondent | Rd Hibbert RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-28 |
Decision Date | 1992-12-18 |