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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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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