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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cranial
510(k) Number K213587
Device Name MyCRO Band
Applicant
Otto Bock Healthcare LP
3820 W. Great Lakes Dr.
Salt Lake City,  UT  84120
Applicant Contact Caleb Beck
Correspondent
Strategic Quality Solutions, LLC
1594 E. Monaco Ave.
Salt Lake City,  UT  84121
Correspondent Contact Adrienne von Foller
Regulation Number882.5970
Classification Product Code
MVA  
Subsequent Product Code
OAN  
Date Received11/12/2021
Decision Date 06/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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