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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 K960585
Device Name WOUND CARE COMPRESSION SYSTEM (WCCS)
Applicant
SUNCOAST MEDICAL PRODUCTS, INC.
911 LAKESIDE DR.
CARGO,  FL  33778
Applicant Contact JACK S BOROWSKY
Correspondent
SUNCOAST MEDICAL PRODUCTS, INC.
911 LAKESIDE DR.
CARGO,  FL  33778
Correspondent Contact JACK S BOROWSKY
Regulation Number880.5075
Classification Product Code
MCY  
Date Received02/12/1996
Decision Date 04/26/1996
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
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