CCPD CYCLER SET W/5 PRONGED CONNECTOR

System, Peritoneal, Automatic Delivery

AMERICAN MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by American Medical Products, Inc. with the FDA for Ccpd Cycler Set W/5 Pronged Connector.

Pre-market Notification Details

Device IDK822545
510k NumberK822545
Device Name:CCPD CYCLER SET W/5 PRONGED CONNECTOR
ClassificationSystem, Peritoneal, Automatic Delivery
Applicant AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold,  NJ  07728
ContactJoseph J Butler
CorrespondentJoseph J Butler
AMERICAN MEDICAL PRODUCTS, INC. P.O. DRAWER 190 Freehold,  NJ  07728
Product CodeFKX  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-23
Decision Date1982-10-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.