510(k) K101538

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) by Philips Electronics UK Limited — Product Code HGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2010
Date Received
June 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type