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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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More FDA Info for this Product Code
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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