FDA.report

510(k) K990852

Device
COOPERSURGICAL INFRARED COAGULATOR
Applicant
COOPERSURGICAL, INC.
510(k) number
K990852
Product code
KNS  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-11
Date received
1999-03-15
Regulation
876.4300
Classification name
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JONATHAN S KAHAN
Address
555 Thirteenth St. NW Washington DC US 20004 20004

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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