510(k) K822549

CCPD CYCLER SET W/5 PRONGED SAFE LOCK by American Medical Products, Inc. — Product Code FKX

K822549 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "CCPD CYCLER SET W/5 PRONGED SAFE LOCK". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. American Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
August 24, 1982
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