FDA 510(k) Application Details - DEN230015

Device Classification Name

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510(K) Number DEN230015
Device Name Osteoboost Belt
Applicant Bone Health Technologies, Inc
370 Convention Way
Suite 218
Redwood City, CA 94063 US
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Contact Laura Yecies
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Regulation Number

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Classification Product Code QZO
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Date Received 02/17/2023
Decision Date 01/12/2024
Decision DENG -
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review

FDA Source Information for DEN230015


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