510(k) K053494

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE by Fertipro NV — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2006
Date Received
December 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type