FDA 510(k) Application Details - K241492

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

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510(K) Number K241492
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant JJGC Ind·stria e ComΘrcio de Materiais Dentßrios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
Curitiba 81270-200 BR
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Contact Leticia Milani
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 05/28/2024
Decision Date 08/23/2024
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

FDA Source Information for K241492


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