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510(k) K103028

EEVATM PETRI DISH by Auxogyn, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2011
Date Received
October 13, 2010
Clearance Type
Traditional
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)
  • K141663 — EEVA DISH (WITH 12 MICROWELLS) (July 22, 2014)
  • DEN120015 — EEVA 2.0 (June 6, 2014)

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