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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K934528
Device Name 2C LENS FOG REDUCTION & CLEANING DEVICE
Applicant
H & C Chemical, Inc.
100 N. 6th St.
Suite 960c
Minneapolis,  MN  55403
Applicant Contact BRIAN BUTLER
Correspondent
H & C Chemical, Inc.
100 N. 6th St.
Suite 960c
Minneapolis,  MN  55403
Correspondent Contact BRIAN BUTLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/17/1993
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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