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FDA 510(k) Application Details - K080745
Device Classification Name
Pump, Portable, Aspiration (Manual Or Powered)
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510(K) Number
K080745
Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Applicant
GENADYNE BIOTECHNOLOGIES, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
JOHN PAPPAN
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Regulation Number
878.4780
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Classification Product Code
BTA
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More FDA Info for this Product Code
Date Received
03/17/2008
Decision Date
07/30/2008
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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