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 IDK201426
510k NumberK201426
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 Received2020-05-29
Decision Date2021-03-26


Device IdentifiersubmissionNumberSupplement
04064409000104 K201426 000
04064409000029 K201426 000
04064409000036 K201426 000
04064409000043 K201426 000
04064409000050 K201426 000
04064409000067 K201426 000
04064409000074 K201426 000
04064409000081 K201426 000
04064409000098 K201426 000
04064409000012 K201426 000

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