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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 K952420
Device Name STERIGAUZE WET DRESSING
Applicant
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact BEN WALTHALL
Correspondent
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact BEN WALTHALL
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/23/1995
Decision Date 07/12/1995
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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