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FDA 510(k) Application Details - K962789
Device Classification Name
Motor, Surgical Instrument, Ac-Powered
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510(K) Number
K962789
Device Name
Motor, Surgical Instrument, Ac-Powered
Applicant
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact
TEDD GOSIAN
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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
07/17/1996
Decision Date
08/14/1996
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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