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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K905022
Device Name AQUA-GARD WATERPROOF WOUND PATCH
Applicant
Bellhouse Medical, Inc.
2933 Manning Ave. N.
Lake Elmo,  MN  55042
Applicant Contact JULIA LORD
Correspondent
Bellhouse Medical, Inc.
2933 Manning Ave. N.
Lake Elmo,  MN  55042
Correspondent Contact JULIA LORD
Regulation Number880.5240
Classification Product Code
KGX  
Date Received11/07/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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