510(k) K831716

CAPD - CATHETER ADAPTER by American Mcgaw — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
May 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type