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FDA 510(k) Application Details - K090258
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
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510(K) Number
K090258
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
TALLEY MEDICAL
1070 E. WIELAND RD.
LANSING, MI 48906 US
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Contact
JACK VAN DYKE
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Regulation Number
878.4780
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Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
02/02/2009
Decision Date
08/25/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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