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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vacuum Sample, With Anticoagulant
510(k) Number K882501
Device Name ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact ALAN B HERSHMAN
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact ALAN B HERSHMAN
Regulation Number862.1675
Classification Product Code
GIM  
Date Received06/17/1988
Decision Date 07/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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