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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cutter, surgical
510(k) Number K770304
Device Name CUTTER, P605 GENERAL PURPOSE
Applicant
DENTRONIX INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DENTRONIX INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
FZT  
Date Received02/16/1977
Decision Date 03/09/1977
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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