The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Capd Belt.
Device ID | K822547 |
510k Number | K822547 |
Device Name: | CAPD BELT |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | AMERICAN MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-09-09 |