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510(k) K163091

VibraPEP by Medica Holdings, LLC — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2017
Date Received
November 4, 2016
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

  • K172956 — Medicant Mucosal Atomizer (April 6, 2018)
  • K153441 — VibraPEP (March 25, 2016)

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