FDA.report

510(k) K952652

Device
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
Applicant
MEDSCAND (USA), INC.
510(k) number
K952652
Product code
HHK  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-15
Date received
1995-06-09
Regulation
884.1175
Classification name
Curette, Suction, Endometrial (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
TENNY P TSE
Address
P.O. Box 7733 Hollywood FL US 33081 33081

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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