FDA.report

510(k) K974914

Device
SHELHIGH NO-REACT PERICARDIAL PATCHES
Applicant
SHELHIGH, INC.
510(k) number
K974914
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-03
Date received
1997-12-08
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
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
SHLOMO GABBAY
Address
P.O. Box 884 Millburn NJ US 07041 07041

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases