510(k) K980145

AMT DECOMPRESSION TUBES by Applied Medical Technology, Inc. — Product Code KGC

K980145 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT DECOMPRESSION TUBES". The FDA issued a decision of Substantially Equivalent on April 10, 1998. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1998
Date Received
January 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Gastro-Enterostomy
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type