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FDA 510(k) Application Details - K961239
Device Classification Name
Gown, Surgical
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510(K) Number
K961239
Device Name
Gown, Surgical
Applicant
DEPUY, INC.
2747 ARMSTRONG LN.
DAYTON, OH 45414 US
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Contact
CHERYL HASTINGS
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Regulation Number
878.4040
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Classification Product Code
FYA
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More FDA Info for this Product Code
Date Received
04/01/1996
Decision Date
09/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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