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FDA 510(k) Application Details - K031549
Device Classification Name
Light, Headband, Surgical
More FDA Info for this Device
510(K) Number
K031549
Device Name
Light, Headband, Surgical
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
Other 510(k) Applications for this Company
Contact
DAVID KLEMENTOWSKI
Other 510(k) Applications for this Contact
Regulation Number
886.4335
More FDA Info for this Regulation Number
Classification Product Code
FSR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/16/2003
Decision Date
08/11/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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