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FDA 510(k) Application Details - K050519
Device Classification Name
Motor, Surgical Instrument, Ac-Powered
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510(K) Number
K050519
Device Name
Motor, Surgical Instrument, Ac-Powered
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
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Contact
ELIZABETH PAUL
Other 510(k) Applications for this Contact
Regulation Number
878.4820
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Classification Product Code
GEY
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More FDA Info for this Product Code
Date Received
03/01/2005
Decision Date
05/17/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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