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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, electrosurgical
510(k) Number K890973
Device Name STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE
Applicant
INSTRUMENT MAKAR, INC.
2950 EAST MT. HOPE RD.
OKEMOS,  MI  48864
Applicant Contact RICK L MASTERS
Correspondent
INSTRUMENT MAKAR, INC.
2950 EAST MT. HOPE RD.
OKEMOS,  MI  48864
Correspondent Contact RICK L MASTERS
Regulation Number878.4400
Classification Product Code
JOS  
Date Received02/27/1989
Decision Date 03/22/1989
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
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