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510(k) K160758

PeriCoach OTC by Analytica, Ltd. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2016
Date Received
March 18, 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 Analytica, Ltd.

  • K143580 — PeriCoach (March 18, 2015)

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