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510(k) K032208

MONA LISA ASPIRATION NEEDLE by Fertility Technology Resources, Inc. — Product Code MQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2003
Date Received
July 18, 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

Other clearances by Fertility Technology Resources, Inc.

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  • K023017 — TUCKER EMBRYO CATHETER (December 13, 2002)
  • K992307 — EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CA (September 13, 1999)

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