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510(k) K032015

EMBRYON ULTRASOUND NEEDLE GUIDE by Rocket Medical Plc — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2003
Date Received
June 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6100
Review Panel
OB
Submission Type

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