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510(k) K221576

Ameda Pearl Electric Breast Pump by Ameda, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2022
Date Received
June 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Ameda, Inc.

  • K203570 — Mya Joy PLUS Breast Pump (April 22, 2021)

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