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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tray, surgical, instrument
510(k) Number K844286
Device Name FLASH GUARD PLASTIC VERSION
Applicant
SPARCO, INC.
P.O. BOX 20369
CASTRO VALLEY,  CA  94546
Applicant Contact BEVERLY J SPARKS
Correspondent
SPARCO, INC.
P.O. BOX 20369
CASTRO VALLEY,  CA  94546
Correspondent Contact BEVERLY J SPARKS
Regulation Number878.4800
Classification Product Code
FSM  
Date Received11/05/1984
Decision Date 11/19/1984
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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