The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Cholangiography Clamp.
Device ID | K924480 |
510k Number | K924480 |
Device Name: | CHOLANGIOGRAPHY CLAMP |
Classification | Catheter, Cholangiography |
Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
Contact | Ho Stegwell |
Correspondent | Ho Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-03 |
Decision Date | 1993-03-03 |