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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 K901756
Device Name INTERJECTOR BLOOD COLLECTION DEVICE
Applicant
Bowman/Vector, Inc.
3621 N.W,23rd.St.
Fort Lauderdale,  FL  33311
Applicant Contact BLAIR, PA
Correspondent
Bowman/Vector, Inc.
3621 N.W,23rd.St.
Fort Lauderdale,  FL  33311
Correspondent Contact BLAIR, PA
Regulation Number862.1675
Classification Product Code
JKA  
Date Received04/17/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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