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510(k) K153441

VibraPEP by Medica Holdings, LLC — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2016
Date Received
November 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by Medica Holdings, LLC

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  • K163091 — VibraPEP (February 21, 2017)

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