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510(k) K132870

Origio Gas Line Filter by Origio, Inc. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2014
Date Received
September 13, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

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  • K140317 — EMBRYOGEN (June 16, 2014)
  • K133912 — ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIA (May 14, 2014)

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