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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K030574
Device Name GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
Applicant
Glustitch, Inc.
# 307 7188 Progress Way
Delta,  CA V4G 1M6
Applicant Contact DON BLACKLOCK
Correspondent
Glustitch, Inc.
# 307 7188 Progress Way
Delta,  CA V4G 1M6
Correspondent Contact DON BLACKLOCK
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/24/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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