FDA 510(k) Application Details - K952975

Device Classification Name Exerciser, Powered

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510(K) Number K952975
Device Name Exerciser, Powered
Applicant PREVENT PRODUCTS, INC.
1167 OTTAWA AVE.
W ST PAUL, MN 55118 US
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Contact CAROL GARCIA
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Regulation Number 890.5380

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Classification Product Code BXB
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Date Received 06/27/1995
Decision Date 09/25/1996
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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