510(k) K910656

WILSON-COOK DISPOSABLE BIOPSY FORCEPS by Wilson-Cook Medical, Inc. — Product Code FLC

K910656 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK DISPOSABLE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code FLC (Station, Dialysis Control, Negative Pressure Type), a Class II device regulated under 21 CFR 876.5820. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1991
Date Received
February 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Dialysis Control, Negative Pressure Type
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type