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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K083275
Device Name PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
Applicant
MAX ENDOSCOPY INC.
1410 HIGHLAND ROAD, SUITE 6
MACEDONIA,  OH  44056
Applicant Contact MICHAEL WOLF
Correspondent
MAX ENDOSCOPY INC.
1410 HIGHLAND ROAD, SUITE 6
MACEDONIA,  OH  44056
Correspondent Contact MICHAEL WOLF
Regulation Number876.4300
Classification Product Code
KNS  
Date Received11/06/2008
Decision Date 06/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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