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510(k) K172835

GRI-Alleset Veress Needle by Gri Medical and Electronic Technology Co., Ltd. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2018
Date Received
September 19, 2017
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 Gri Medical and Electronic Technology Co., Ltd.

  • K172712 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Tod (November 6, 2017)
  • K111458 — GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS (December 1, 2011)
  • K102652 — NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED (February 3, 2011)

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