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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, surgical, general & plastic surgery
510(k) Number K883255
Device Name KOMET SURGICAL BUR
Applicant
KOMET MEDICAL, DIV. OF BRASSELER USA I, L.P.
800 KING GEORGE BLVD.
SAVANNAH,  GA  31419
Applicant Contact LONNIE COLLINSWORTH
Correspondent
KOMET MEDICAL, DIV. OF BRASSELER USA I, L.P.
800 KING GEORGE BLVD.
SAVANNAH,  GA  31419
Correspondent Contact LONNIE COLLINSWORTH
Regulation Number878.4820
Classification Product Code
GFF  
Date Received08/02/1988
Decision Date 09/15/1988
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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