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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 K933618
Device Name EAGLE MEDICAL ANTI-FOG KIT
Applicant
Eagle Medical Intl.
18 Crestwood Dr.
Trophy Club,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
Eagle Medical Intl.
18 Crestwood Dr.
Trophy Club,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
OCT  
Date Received07/19/1993
Decision Date 03/07/1994
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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