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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K913480
Device Name WOUND CARE TRAY A
Applicant
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Applicant Contact J ROGOZINSKI
Correspondent
Catalina Biomedical Corp.
1850 Evergreen St.
Duarte,  CA  91010
Correspondent Contact J ROGOZINSKI
Regulation Number880.5075
Classification Product Code
MCY  
Date Received08/06/1991
Decision Date 10/18/1991
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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