FDA.report

510(k) K964467

Device
SHELHIGH PERICARDIAL PATCH
Applicant
SHELHIGH, INC.
510(k) number
K964467
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-09-23
Date received
1996-11-07
Regulation
870.3470
Classification name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
SHLOMO GABBAY, M.D.
Address
67 E. Willow St. Millburn NJ US 07041 07041

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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