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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, unipolar (and accessories)
510(k) Number K924200
Device Name REFLEX(R) ESC
Applicant
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
RICHARD-ALLAN MEDICAL IND., INC.
8850 M89
BOX 351
RICHLAND,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number884.4160
Classification Product Code
KNF  
Date Received08/20/1992
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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