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510(k) K840946

MICROPOROUS HYPOALLERGENIC by Gainor Medical — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
March 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ring (Wound Protector), Drape Retention, Internal
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

Other clearances by Gainor Medical

  • K850100 — BLOOD LANCET (January 29, 1987)
  • K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (February 21, 1985)
  • K844305 — GAINOR MEDICAL FLOWMAX NEEDLES (November 30, 1984)
  • K844306 — GAINOR MEDICAL SYRINGE (November 30, 1984)
  • K840950 — ZINC OXIDE TAPE (October 31, 1984)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K840951 — FIRST AID BANDAGE (October 31, 1984)
  • K840949 — CLEAR PLASTIC-HYPOALLERGENIC (August 17, 1984)
  • K840947 — CLOTH-HYPOALLERGENIC (August 17, 1984)
  • K840948 — CLEAR POROUS PLASTIC-HYPOALLERGENIC (August 14, 1984)

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  • K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR (April 2, 2010)
  • K093296 — ALEXIS LAPAROSCOPIC SYSTEM (November 5, 2009)
  • K062907 — ALEXIS WOUND RETRACTOR (January 9, 2007)
  • K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (August 26, 2004)
  • K790306 — EDGE PROTECTOR, BARRIER (February 22, 1979)