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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 K902709
Device Name SECUTAINER
Applicant
PRESERVE
32255 NORTHWESTERN HWY.
SUITE 254
FARMINGTON HILLS,  MI  48018
Applicant Contact MAURICE REISMAN
Correspondent
PRESERVE
32255 NORTHWESTERN HWY.
SUITE 254
FARMINGTON HILLS,  MI  48018
Correspondent Contact MAURICE REISMAN
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/20/1990
Decision Date 07/27/1990
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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