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510(k) K142700

InsufflatOR Needle by Gynetech Pty. , Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
September 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Gynetech Pty. , Ltd.

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  • K142164 — MANIPULATOR; MANIPULATOR PRO (December 17, 2014)
  • K051594 — MCCARTNEY ACCESS TUBE (September 2, 2005)

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