The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Cardiac Cath Or Angiographic Trays.
Device ID | K932218 |
510k Number | K932218 |
Device Name: | CARDIAC CATH OR ANGIOGRAPHIC TRAYS |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Contact | Scott Weiss |
Correspondent | Scott Weiss ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-07 |
Decision Date | 1993-08-27 |