FDA 510(k) Application Details - K242146

Device Classification Name Dressing, Wound, Collagen

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510(K) Number K242146
Device Name Dressing, Wound, Collagen
Applicant Smith & Nephew Medical Limited
101 Hessle Road
Hull HU3 2BN GB
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Contact Andrew Daglish
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Regulation Number 000.0000

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Classification Product Code KGN
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Date Received 07/23/2024
Decision Date 12/17/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242146


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