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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, neurological
510(k) Number K210251
Device Name ClearPath Disposable Introducer
Applicant
ClearMind Biomedical
5F, No. 167, Fuxing N. Rd., Songshan Dist.
Taipei,  TW 105403
Applicant Contact Sheng-Chi (aka Vance Lin) Lin
Correspondent
Coombs Medical Device Consulting, Inc.
1100 Pacific Marina, Suite 806
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number882.1480
Classification Product Code
GWG  
Date Received01/29/2021
Decision Date 04/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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