510(k) K810600

CAPD EXCHANGE SET by American Mcgaw — Product Code KDJ

K810600 is an FDA 510(k) premarket notification submitted by American Mcgaw for the device "CAPD EXCHANGE SET". The FDA issued a decision of Substantially Equivalent on March 24, 1981. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. American Mcgaw has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1981
Date Received
March 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type