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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K192526
Device Name Spine Wave Navigated Instruments
Applicant
Spine Wave, Inc.
3 Enterprise Drive, Suite 210
Shelton,  CT  06484
Applicant Contact Amy Noccioli
Correspondent
Spine Wave, Inc.
3 Enterprise Drive, Suite 210
Shelton,  CT  06484
Correspondent Contact Amy Noccioli
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/13/2019
Decision Date 10/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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