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FDA 510(k) Application Details - K083752
Device Classification Name
Bandage, Liquid
More FDA Info for this Device
510(K) Number
K083752
Device Name
Bandage, Liquid
Applicant
GLUSTITCH, INC.
#307 7188 PROGRESS WAY
DELTA, B.C. V4G 1M6 CA
Other 510(k) Applications for this Company
Contact
DON BLACKLOCK
Other 510(k) Applications for this Contact
Regulation Number
880.5090
More FDA Info for this Regulation Number
Classification Product Code
KMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2008
Decision Date
02/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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