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FDA 510(k) Application Details - K202592
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K202592
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Stryker
5900 Optical Ct
San Jose, CA 95138 US
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Contact
Divya Sekar
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
09/08/2020
Decision Date
10/08/2020
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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