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510(k) K190465

Evolve Breast Pump by Hygeia II Medical Group, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2019
Date Received
February 26, 2019
Clearance Type
Special
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 Hygeia II Medical Group, Inc.

  • K233136 — Hygeia Express Powered Breast Pump (March 13, 2024)
  • K212955 — Fit Pro Breast Pump (March 15, 2022)
  • K200406 — Evolve Breast Pump (March 18, 2020)

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