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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K220231
Device Name GyroStim
Applicant
UltraThera Technologies, Inc.
2 North Cascade Avenue, Suite 640
Colorado Springs,  CO  80903
Applicant Contact Kevin Maher
Correspondent
UltraThera Technologies, Inc.
2 North Cascade Avenue, Suite 640
Colorado Springs,  CO  80903
Correspondent Contact Kevin Maher
Classification Product Code
LXV  
Date Received01/27/2022
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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