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FDA 510(k) Application Details - K050256
Device Classification Name
Retractor
More FDA Info for this Device
510(K) Number
K050256
Device Name
Retractor
Applicant
APPLE MEDICAL CORP.
75 FEDERAL STREET, 9TH FL
BOSTON, MA 02110 US
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Contact
JAMES DELANEY
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
GAD
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More FDA Info for this Product Code
Date Received
02/03/2005
Decision Date
04/26/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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