FDA 510(k) Application Details - K973929

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K973929
Device Name Stimulator, Muscle, Powered
Applicant NEOTONUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact JAMES R VEALE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 10/15/1997
Decision Date 05/21/1998
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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