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510(k) K033904

PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) by Cook Urological, Inc. — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2004
Date Received
December 17, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

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