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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, non-electric
510(k) Number K933135
Device Name DAWN DISPOSABLE BIOPSY FORCEPS
Applicant
DAWN MEDICAL
414 WHITEHALL DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact ALAN GOLDENBERG
Correspondent
DAWN MEDICAL
414 WHITEHALL DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact ALAN GOLDENBERG
Regulation Number876.1075
Classification Product Code
FCL  
Date Received06/28/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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