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FDA 510(k) Application Details - K031828
Device Classification Name
Forceps, General & Plastic Surgery
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510(K) Number
K031828
Device Name
Forceps, General & Plastic Surgery
Applicant
FOCUS MEDICAL, LLC.
23 FRANCIS J. CLARKE CIRCLE
BETHEL, CT 06801 US
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Contact
JOHN LEE, JR
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
GEN
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More FDA Info for this Product Code
Date Received
06/13/2003
Decision Date
07/17/2003
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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