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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 K181199
Device Name Katalyst Mark 1 Muscle Stimulation System Model 2
Applicant
Katalyst Inc.
316 Occidental Ave.
South Suite B300
Seattle,  WA  98104
Applicant Contact Bjoern Woltermann
Correspondent
Katalyst Inc.
316 Occidental Ave.
South Suite B300
Seattle,  WA  98104
Correspondent Contact Bjoern Woltermann
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/07/2018
Decision Date 09/20/2018
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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