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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 K934186
Device Name FORCEPS, BIOPSY, GASTROINTESTINAL
Applicant
Primed Instruments, Inc.
17 Oxenden Crescent
Etobicoke, Ontario, Canada
M9c 4h3,  CA
Applicant Contact JACEK KRZYZANOWSKI
Correspondent
Primed Instruments, Inc.
17 Oxenden Crescent
Etobicoke, Ontario, Canada
M9c 4h3,  CA
Correspondent Contact JACEK KRZYZANOWSKI
Regulation Number876.1075
Classification Product Code
FCL  
Date Received08/26/1993
Decision Date 12/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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