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510(k) K162689

Vibrance Pelvic Trainer by Bioinfinity (M) Sdn. Bhd. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2017
Date Received
September 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Bioinfinity (M) Sdn. Bhd.

  • K141893 — VIBRANCE KEGEL DEVICE (VKD) (December 18, 2014)

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