FDA 510(k) Application Details - K221613

Device Classification Name

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510(K) Number K221613
Device Name Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
Applicant Owen Mumford Ltd
Owen Mumford, Brook Hill, Woodstock
Woodstock OX20 ITU GB
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Contact Darren Mansell
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Regulation Number

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Classification Product Code QRL
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Date Received 06/03/2022
Decision Date 10/03/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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