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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 K974454
Device Name CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
Applicant
Tucson Medical Corp.
3941 E. 29th St., Suite 601
Tucson,  AZ  85711
Applicant Contact JIM PATKO
Correspondent
Tucson Medical Corp.
3941 E. 29th St., Suite 601
Tucson,  AZ  85711
Correspondent Contact JIM PATKO
Regulation Number876.1500
Classification Product Code
OCT  
Date Received11/25/1997
Decision Date 12/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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