MyCRO Band

Orthosis, Cranial

Otto Bock Healthcare LP

The following data is part of a premarket notification filed by Otto Bock Healthcare Lp with the FDA for Mycro Band.

Pre-market Notification Details

Device IDK213587
510k NumberK213587
Device Name:MyCRO Band
ClassificationOrthosis, Cranial
Applicant Otto Bock Healthcare LP 3820 West Great Lakes Drive Salt Lake City,  UT  84120
ContactCaleb Beck
CorrespondentAdrienne Von Foller
Strategic Quality Solutions, LLC 1594 E. Monaco Ave Salt Lake City,  UT  84121
Product CodeMVA  
CFR Regulation Number882.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-12
Decision Date2022-06-09

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