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510(k) K100120

ALEXIS ORTHOPAEDIC WOUND RETRACTOR by Applied Medical Resources Corp. — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
January 15, 2010
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

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Other clearances for product code KGW

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  • 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)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)
  • K790306 — EDGE PROTECTOR, BARRIER (February 22, 1979)