510(k) K900035

WILSON-COOK COLON DECOMPRESSION SET by Wilson-Cook Medical, Inc. — Product Code FEG

K900035 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "WILSON-COOK COLON DECOMPRESSION SET". The FDA issued a decision of Substantially Equivalent on March 7, 1990. The device falls under product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation), a Class II device regulated under 21 CFR 876.5980. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1990
Date Received
January 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type