FDA 510(k) Application Details - K231668

Device Classification Name

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510(K) Number K231668
Device Name Spine CAMPÖ (1.1)
Applicant Medical Metrics, Inc.
2121 Sage Road
Suite 300
Houston, TX 77056 US
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Contact Kirk Johnson
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Regulation Number

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Classification Product Code QIH
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Date Received 06/07/2023
Decision Date 07/07/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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