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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 K945732
Device Name FOG FREE
Applicant
Tonn Chemical Co., Inc.
3150 N. A1a Ph3-3
Fort Pierce,  FL  34949
Applicant Contact CLAUS D TONN
Correspondent
Tonn Chemical Co., Inc.
3150 N. A1a Ph3-3
Fort Pierce,  FL  34949
Correspondent Contact CLAUS D TONN
Regulation Number876.1500
Classification Product Code
OCT  
Date Received11/23/1994
Decision Date 01/04/1995
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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