The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Capd Safe Lock Transfer Set.
Device ID | K822543 |
510k Number | K822543 |
Device Name: | CAPD SAFE LOCK TRANSFER SET |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
Contact | Joseph J Butler |
Correspondent | Joseph J Butler AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-23 |
Decision Date | 1982-10-13 |