510(k) K894870

WILTEK NASAL BILIARY DRAINAGE SET by Wiltek Medical, Inc. — Product Code BSS

K894870 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK NASAL BILIARY DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1989
Date Received
July 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Nasogastric
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type