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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K981796
Device Name LIGHT SABER CORE TISSUE NEEDLE
Applicant
MINRAD, INC.
6576 EAST QUAKER ST.
ORCHARD PARK,  NY  14127 -2593
Applicant Contact THOMAS L PARKER
Correspondent
MINRAD, INC.
6576 EAST QUAKER ST.
ORCHARD PARK,  NY  14127 -2593
Correspondent Contact THOMAS L PARKER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/21/1998
Decision Date 08/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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