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FDA 510(k) Application Details - K181199
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
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510(K) Number
K181199
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Katalyst Inc.
316 Occidental Ave.
South Suite B300
Seattle, WA 98104 US
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Contact
Bjoern Woltermann
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Regulation Number
890.5850
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Classification Product Code
NGX
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More FDA Info for this Product Code
Date Received
05/07/2018
Decision Date
09/20/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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