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510(k) K061371

SYDNEY IVF SPERM CRYOPRESERVATION BUFFER by Cook Urological, Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2006
Date Received
May 17, 2006
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

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