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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K171035
Device Name Katalyst Mark 1 Muscle Stimulation System
Applicant
Katalyst Inc.
316 Occidental Ave.
South B300
Seattle,  WA  98104
Applicant Contact Amish Patel
Correspondent
Katalyst Inc.
316 Occidental Ave.
South B300
Seattle,  WA  98104
Correspondent Contact Amish Patel
Regulation Number890.5850
Classification Product Code
NGX  
Date Received04/06/2017
Decision Date 09/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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