510(k) K960176

DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER by C.R. Bard, Inc. — Product Code FEG

K960176 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER". The FDA issued a decision of Substantially Equivalent on July 24, 1996. 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. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1996
Date Received
January 16, 1996
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