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510(k) K061539

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE by Clinical Innovations, LLC — Product Code HFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2007
Date Received
June 5, 2006
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

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Other clearances for product code HFX

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  • K151095 — Circumplast Circumcision Device (September 18, 2015)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (April 20, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
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  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K063429 — GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 (January 17, 2007)