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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
Other 510(k) Applications for this Contact
Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
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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