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510(k) K062907

ALEXIS WOUND RETRACTOR by Applied Medical Resources — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2007
Date Received
September 27, 2006
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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  • K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (August 26, 2004)
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