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FDA 510(k) Application Details - K970886
Device Classification Name
Light, Surgical, Floor Standing
More FDA Info for this Device
510(K) Number
K970886
Device Name
Light, Surgical, Floor Standing
Applicant
HERAEUS MED GMBH
HERAEUSSTRASSE 12-14
HANAU D-63450 DE
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Contact
MARK SCHULZ
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FSS
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More FDA Info for this Product Code
Date Received
02/06/1997
Decision Date
04/16/1997
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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