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FDA 510(k) Application Details - K965130
Device Classification Name
Light, Surgical, Ceiling Mounted
More FDA Info for this Device
510(K) Number
K965130
Device Name
Light, Surgical, Ceiling Mounted
Applicant
BERCHTOLD HOLDING GMBH
LUDWIGSTALER STR. 25
TUTTLINGEN D-78532 DE
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Contact
W. HILL
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FSY
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More FDA Info for this Product Code
Date Received
12/23/1996
Decision Date
07/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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