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FDA 510(k) Application Details - K081185
Device Classification Name
Pump, Portable, Aspiration (Manual Or Powered)
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510(K) Number
K081185
Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Applicant
OHIO MEDICAL CORPORATION
1111 LAKESIDE DR.
GURNEE, IL 60031 US
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DAVID PLATT
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Regulation Number
878.4780
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Classification Product Code
BTA
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Date Received
04/25/2008
Decision Date
05/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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