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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K974374
Device Name SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
Applicant
Ohmeda Medical
100 Mountain Ave.
Murray Hill,  NJ  07974
Applicant Contact JING ZHANG
Correspondent
Ohmeda Medical
100 Mountain Ave.
Murray Hill,  NJ  07974
Correspondent Contact JING ZHANG
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/20/1997
Decision Date 01/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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