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FDA 510(k) Application Details - K010716
Device Classification Name
Light, Surgical, Ceiling Mounted
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510(K) Number
K010716
Device Name
Light, Surgical, Ceiling Mounted
Applicant
VAL MED CORP.
555 THIRTEENTH ST. N.W.
COLUMBIA SQUARE
WASHINGTON, DC 20004 US
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Contact
HOWARD M HOLSTEIN
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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
03/09/2001
Decision Date
05/30/2001
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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