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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 K904871
Device Name MEDI-KLEER
Applicant
North American Marketing Corp.
P.O. Box 1029
Santa Ynez,  CA  93460
Applicant Contact PAMELA G GOFORTH
Correspondent
North American Marketing Corp.
P.O. Box 1029
Santa Ynez,  CA  93460
Correspondent Contact PAMELA G GOFORTH
Regulation Number876.1500
Classification Product Code
OCT  
Date Received10/29/1990
Decision Date 09/17/1991
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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