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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, photographic, for endoscope (exclude light sources)
510(k) Number K812201
Device Name PHOTOGRAPHIC EQUIPMENT
Applicant
REZNIK INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
REZNIK INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FEM  
Date Received08/04/1981
Decision Date 10/19/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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