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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 K951914
Device Name HYDRACARE ABSORBENT WOUND DRESSING
Applicant
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact PHILIP L RITGER
Correspondent
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact PHILIP L RITGER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/24/1995
Decision Date 05/15/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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