Neurological Stereotaxic Instrument

InTRAvent Medical Partners, LP

The following data is part of a premarket notification filed by Intravent Medical Partners, Lp with the FDA for Solopass System.

Pre-market Notification Details

Device IDK203251
510k NumberK203251
Device Name:SOLOPASS System
ClassificationNeurological Stereotaxic Instrument
Applicant inTRAvent Medical Partners, LP 421 W. Chocolate Ave. Hershey,  PA  17036
ContactAdam Barner
CorrespondentConnie Qiu
M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York,  NY  10001
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-04
Decision Date2021-08-27

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