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510(k) K041711

ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 by Applied Medical Resources Corp. — Product Code KGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2004
Date Received
June 23, 2004
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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