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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
Predetermined Change
Control Plan Authorized		 No
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