The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Flexible Laparoscopic Cholangiography Catheter.
Device ID | K944790 |
510k Number | K944790 |
Device Name: | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER |
Classification | Catheter, Cholangiography |
Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
Contact | Mary Jo Stegwell |
Correspondent | Mary Jo 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 | 1994-09-28 |
Decision Date | 1994-11-29 |