FDA.report

510(k) K972630

Device
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
Applicant
COOPERSURGICAL, INC.
510(k) number
K972630
Product code
HEX  
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-02
Date received
1997-07-14
Regulation
884.1630
Classification name
Colposcope (and Colpomicroscope)
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
SHEILA HEMEON-HEYER
Address
49 Plain St. North Attleboro MA US 02760 02760

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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