FDA 510(k) Application Details - K203359

Device Classification Name Syringe, Piston

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510(K) Number K203359
Device Name Syringe, Piston
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact Nikita Abirami Mahendra Kumar
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 11/16/2020
Decision Date 07/28/2021
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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