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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 K170722
Device Name Moxxly Flow Collection System
Applicant
Moxxly, Inc.
1777 Yosemite Ave. Suite 235
San Francisco,  CA  94124
Applicant Contact Cara Delzer
Correspondent
Moxxly, Inc.
1777 Yosemite Ave. Suite 235
San Francisco,  CA  94124
Correspondent Contact Rory A. Carrillo
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/09/2017
Decision Date 08/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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