The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Internal Mammary Artery Cannula.
Device ID | K960098 |
510k Number | K960098 |
Device Name: | RMI INTERNAL MAMMARY ARTERY CANNULA |
Classification | Cannula, Catheter |
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 | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-11 |
Decision Date | 1996-03-26 |
Summary: | summary |