Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221611
Device Classification Name
More FDA Info for this Device
510(K) Number
K221611
Device Name
780 nm L11 LED Light Source with AIM
Applicant
Stryker
5900 Optical Court
San Jose, CA 95138 US
Other 510(k) Applications for this Company
Contact
Michelle Hughes
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
06/03/2022
Decision Date
06/29/2022
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact