FDA 510(k) Application Details - K210810

Device Classification Name Wrap, Sterilization

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510(K) Number K210810
Device Name Wrap, Sterilization
Applicant Wipak OY
Wipaktie 2
Nastola FI-15560 FI
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Contact Mira Santala
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 03/17/2021
Decision Date 01/23/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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