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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K894984
Device Name MASCOT LAB SPONGE
Applicant
Mascot, Inc.
16635 Valley View
Cerritos,  CA  90701
Applicant Contact BEN CHANG
Correspondent
Mascot, Inc.
16635 Valley View
Cerritos,  CA  90701
Correspondent Contact BEN CHANG
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/08/1989
Decision Date 09/05/1989
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
Predetermined Change
Control Plan Authorized		 No
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