FDA 510(k) Application Details - K222640

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K222640
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Sweden & Martina S.p.A.
Via Veneto, 10
Due Carrare 35020 IT
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Contact Alessia Pezzato
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 09/01/2022
Decision Date 05/26/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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