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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric, Reprocessed
510(k) Number K033593
Device Name REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
Applicant
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE,  WA  98005
Applicant Contact MIKE KOVACS
Correspondent
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE,  WA  98005
Correspondent Contact MIKE KOVACS
Regulation Number876.4300
Classification Product Code
NLU  
Date Received11/13/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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