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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tourniquet, Nonpneumatic
510(k) Number K881176
Device Name STERILE ESMARCH BANDAGE
Applicant
SPECTRUM/HYDRO-MED PRODUCTS, INC.
2930 LADYBIRD LN.
DALLAS,  TX  75220
Applicant Contact BONNIE BEASLEY
Correspondent
SPECTRUM/HYDRO-MED PRODUCTS, INC.
2930 LADYBIRD LN.
DALLAS,  TX  75220
Correspondent Contact BONNIE BEASLEY
Regulation Number878.5900
Classification Product Code
GAX  
Date Received03/18/1988
Decision Date 04/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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