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510(k) K260346

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) by Polybell (Guangzhou) Limited — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2026
Date Received
February 3, 2026
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

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