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FDA 510(k) Application Details - K191046
Device Classification Name
More FDA Info for this Device
510(K) Number
K191046
Device Name
L10 LED Light Source with AIM, L11 LED Light Source with AIM
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
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Contact
Agatha Szeliga
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OWN
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More FDA Info for this Product Code
Date Received
04/19/2019
Decision Date
05/10/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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