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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K941648
Device Name BLUE PLANET LENS FOG REDUCTION & CLEANING KIT
Applicant
Blue Planet Industries, Inc.
14224 43rd. Ave. N.
Suite E
Plymouth,  MN  55446
Applicant Contact BRIAN BUTLER
Correspondent
Blue Planet Industries, Inc.
14224 43rd. Ave. N.
Suite E
Plymouth,  MN  55446
Correspondent Contact BRIAN BUTLER
Regulation Number876.1500
Classification Product Code
FEB  
Date Received04/04/1994
Decision Date 05/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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