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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K203251
Device Name SOLOPASS System
Applicant
Intravent Medical Partners, LP
421 W. Chocolate Ave.
Hershey,  PA  17036
Applicant Contact Adam Barner
Correspondent
Msquared Associates, Inc.
127 W. 30th St.,
9th Floor
New York,  NY  10001
Correspondent Contact Connie Qiu
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYN  
Date Received11/04/2020
Decision Date 08/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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