510(k) K030340

AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) by Cytomedix — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2003
Date Received
January 31, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type