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510(k) K945949

KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] by Vlm Surgical, Inc. — Product Code HFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
December 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Vlm Surgical, Inc.

  • K842912 — THE SUTURER (August 15, 1984)

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  • K131373 — SHANGRING (June 25, 2013)
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  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)