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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 K941134
Device Name EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT
Applicant
H & C Chemical, Inc.
100 N. Sixth St.
Suite 960-C
Minneapolis,  MN  55403
Applicant Contact BRIAN BUTLER
Correspondent
H & C Chemical, Inc.
100 N. Sixth St.
Suite 960-C
Minneapolis,  MN  55403
Correspondent Contact BRIAN BUTLER
Regulation Number876.1500
Classification Product Code
FEB  
Date Received03/09/1994
Decision Date 05/16/1994
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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