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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, sponge, surgical
510(k) Number K982260
Device Name MARKWELL GAUZE SPONGE
Applicant
MARKWELL INTL., INC.
2550 WEST MAIN ST. , SUITE 212
ALHAMBRA,  CA  91801
Applicant Contact SEAN WANG
Correspondent
MARKWELL INTL., INC.
2550 WEST MAIN ST. , SUITE 212
ALHAMBRA,  CA  91801
Correspondent Contact SEAN WANG
Regulation Number880.2740
Classification Product Code
LWH  
Subsequent Product Code
EFQ  
Date Received06/26/1998
Decision Date 08/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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