510(k) K791645

VICKERS MEDICAL MODEL 112 TREONIC DC2 by Vickers America Medical Corp. — Product Code FKW

K791645 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "VICKERS MEDICAL MODEL 112 TREONIC DC2". The FDA issued a decision of Substantially Equivalent on October 2, 1979. The device falls under product code FKW (Tip, Vessel), a Class II device regulated under 21 CFR 876.5540. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1979
Date Received
August 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tip, Vessel
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type