510(k) K900035
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