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510(k) K921020

HARGIS SELF RETRACTION SYSTEM by Medin Corp. — Product Code GAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1993
Date Received
March 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Medin Corp.

  • K921019 — HARGIS RECTAL SELF RETRATION SYSTEM (July 2, 1993)
  • K921017 — HARGIS SR2 SELF-RETRACTION SYSTEM (July 2, 1993)
  • K833343 — STERILIZATION CONTAINER (November 3, 1983)
  • K761032 — CRADLING SYSTEM (January 26, 1977)

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  • K071775 — DASH (August 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)