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510(k) K141663

EEVA DISH (WITH 12 MICROWELLS) by Auxogyn, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2014
Date Received
June 23, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Auxogyn, Inc.

  • K142147 — EEVA SYSTEM (November 24, 2014)
  • DEN120015 — EEVA 2.0 (June 6, 2014)
  • K103028 — EEVATM PETRI DISH (August 11, 2011)

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