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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 SOUTH GRAND AVE.
SANTA ANA,  CA  92705 -4808
Applicant Contact PHILIP L RITGER
Correspondent
ACACIA LABORATORIES, INC.
1719 SOUTH GRAND AVE.
SANTA ANA,  CA  92705 -4808
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
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