FDA.report

510(k) K021237

Device
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
Applicant
COOPERSURGICAL, INC.
510(k) number
K021237
Product code
HET  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-10
Date received
2002-04-18
Regulation
884.1720
Classification name
Laparoscope, Gynecologic (and Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
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
HAIKO BELL
Address
Kaiserstr.9 Tuningen DE D-78609 D-78609

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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