HANCOCK PERICARDIAL PATCH

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Hancock Pericardial Patch.

Pre-market Notification Details

Device IDK840262
510k NumberK840262
Device Name:HANCOCK PERICARDIAL PATCH
ClassificationPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDXZ  
CFR Regulation Number870.3470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-19
Decision Date1984-05-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.