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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K923843
Device Name FOGLESS
Applicant
SOREX MEDICAL
5725 WEST HAROLD GATTY DR.
SALT LAKE CITY,  UT  84116
Applicant Contact DOUGLAS JACOB
Correspondent
SOREX MEDICAL
5725 WEST HAROLD GATTY DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact DOUGLAS JACOB
Regulation Number876.1500
Classification Product Code
OCT  
Date Received07/31/1992
Decision Date 03/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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