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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 K070666
Device Name GENESISCS COMPONENT CONCENTRATING SYSTEM
Applicant
PERFUSION PARTNERS & ASSOC. INC.
1970 N. LESLIE RD., NO 220
PAHRUMP,  NV  89060
Applicant Contact NANCY LORD MD. ESQ
Correspondent
PERFUSION PARTNERS & ASSOC. INC.
1970 N. LESLIE RD., NO 220
PAHRUMP,  NV  89060
Correspondent Contact NANCY LORD MD. ESQ
Regulation Number862.2050
Classification Product Code
JQC  
Date Received03/12/2007
Decision Date 06/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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