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FDA 510(k) Application Details - K050957
Device Classification Name
Instrument, Manual, Surgical, General Use
More FDA Info for this Device
510(K) Number
K050957
Device Name
Instrument, Manual, Surgical, General Use
Applicant
SPECIAL DEVICES, INC.
12493 OLD ROUGH AND READY HWY.
GRASS VALLEY, CA 95945 US
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Contact
JOSEPH J SPRANZA III
Other 510(k) Applications for this Contact
Regulation Number
878.4800
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Classification Product Code
MDM
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More FDA Info for this Product Code
Date Received
04/15/2005
Decision Date
05/18/2005
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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