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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 K971111
Device Name TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
Applicant
Tri-Tech, Inc.
4019 Executive Park Blvd.,SE
Southport,  NC  28461
Applicant Contact WENDIE WALKER
Correspondent
Tri-Tech, Inc.
4019 Executive Park Blvd.,SE
Southport,  NC  28461
Correspondent Contact WENDIE WALKER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/26/1997
Decision Date 06/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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