• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-