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510(k) K000205

EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES by Rocket Medical Plc — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2000
Date Received
January 21, 2000
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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  • K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE (August 8, 2003)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)

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