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FDA 510(k) Application Details - K994065
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K994065
Device Name
Stimulator, Muscle, Powered
Applicant
HOME WELLNESS WEST
9393 ACTIVITY RD.
SUITE F
SAN DIEGO, CA 92126 US
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Contact
RICHARD M HARRIS
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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
12/01/1999
Decision Date
04/04/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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