FDA 510(k) Application Details - K955174

Device Classification Name Motor, Surgical Instrument, Pneumatic Powered

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510(K) Number K955174
Device Name Motor, Surgical Instrument, Pneumatic Powered
Applicant SODEM DIFFUSION SA
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact ROSINA ROBINSON
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Regulation Number 878.4820

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Classification Product Code GET
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Date Received 11/13/1995
Decision Date 01/22/1996
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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