FDA 510(k) Application Details - K232006

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K232006
Device Name Sleeve, Limb, Compressible
Applicant IG Technology Ltd
Wylcut House, 316 Petre St
Sheffield S33 0AW GB
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Contact Ivan Green
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 07/06/2023
Decision Date 08/04/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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