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FDA 510(k) Application Details - K960473
Device Classification Name
Motor, Surgical Instrument, Pneumatic Powered
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510(K) Number
K960473
Device Name
Motor, Surgical Instrument, Pneumatic Powered
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
MARY E HOLDEN
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Regulation Number
878.4820
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Classification Product Code
GET
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Date Received
02/01/1996
Decision Date
03/07/1996
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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