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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 K972496
Device Name PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER
Applicant
Tao & Tao Technologyt, Inc.
957 Ashton Place
Carmel,  IN  46033
Applicant Contact PAULINE TAO
Correspondent
Tao & Tao Technologyt, Inc.
957 Ashton Place
Carmel,  IN  46033
Correspondent Contact PAULINE TAO
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/03/1997
Decision Date 12/09/1997
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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