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510(k) K092963

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 by Genx Intl., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
September 25, 2009
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

Other clearances by Genx Intl., Inc.

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  • K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (April 24, 2009)
  • K070689 — LG SPERM FREEZING (July 3, 2007)
  • K020560 — WORKBENCH BY <GENX> (June 19, 2002)
  • K962816 — SPERM PREPARATION MEDIA (November 26, 1996)
  • K963031 — GENXCATHETER (October 21, 1996)

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