The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Lap-cath.
Device ID | K852197 |
510k Number | K852197 |
Device Name: | LAP-CATH |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-20 |
Decision Date | 1985-11-06 |