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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, breast, powered
510(k) Number K203383
Device Name Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
Applicant
Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven,  NL 5656 AE
Applicant Contact Aurore Millet
Correspondent
Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven,  NL 5656 AE
Correspondent Contact Aurore Millet
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/17/2020
Decision Date 12/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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