FDA 510(k) Application Details - K241705

Device Classification Name Pump, Breast, Powered

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510(K) Number K241705
Device Name Pump, Breast, Powered
Applicant MilkMate Products Inc.
780 3rd Avenue
Floor 26
New York, NY 10017 US
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Contact Patrice Meagher
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 06/13/2024
Decision Date 07/12/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241705


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