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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve
510(k) Number K200886
Device Name StimSite
Applicant
Allotrope Medical Inc
2450 Holcombe Blvd., Suite J
Houston,  TX  77021
Applicant Contact Albert Huang
Correspondent
AcKnowledge Regulatory Strategies, LLC
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number874.1820
Classification Product Code
ETN  
Date Received04/02/2020
Decision Date 11/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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