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FDA 510(k) Application Details - K230754
Device Classification Name
More FDA Info for this Device
510(K) Number
K230754
Device Name
L12 LED Light Source with AIM
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
Other 510(k) Applications for this Company
Contact
April Malmborg
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/17/2023
Decision Date
04/11/2023
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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