Cleared Traditional

ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304

K041711 · Applied Medical Resources Corp. · General & Plastic Surgery
Aug 2004
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K041711 is an FDA 510(k) clearance for the ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304, a Ring (wound Protector), Drape Retention, Internal (Class II — Special Controls, product code KGW), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on August 26, 2004, 64 days after receiving the submission on June 23, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K041711 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2004
Decision Date August 26, 2004
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGW — Ring (wound Protector), Drape Retention, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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