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FDA 510(k) Application Details - K182606
Device Classification Name
Laparoscope, General & Plastic Surgery
More FDA Info for this Device
510(K) Number
K182606
Device Name
Laparoscope, General & Plastic Surgery
Applicant
Novadaq Technologies ULC (now a part of Stryker)
8329 Eastlake Drive, Unit 101
Burnaby V5A 4W2 CA
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Contact
Agatha Szeliga
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
09/21/2018
Decision Date
11/21/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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