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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number K024080
Device Name SECQUIRE CELL SEPARATOR
Applicant
PERFUSION PARTNERS & ASSOC. INC.
P.O. BOX 4341
crofton,  MD  21114
Applicant Contact e.j. smith
Correspondent
PERFUSION PARTNERS & ASSOC. INC.
P.O. BOX 4341
crofton,  MD  21114
Correspondent Contact e.j. smith
Regulation Number862.2050
Classification Product Code
JQC  
Date Received12/10/2002
Decision Date 07/02/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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