FDA.report

510(k) K023940

Device
SHELHIGH BIORING
Applicant
SHELHIGH, INC.
510(k) number
K023940
Product code
KRH  
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-04
Date received
2002-11-26
Regulation
870.3800
Classification name
Ring, Annuloplasty
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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
SHLOMO GABBAY
Address
650 Liberty Ave. Union NJ US 07083 07083

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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