The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Hancock Pericardial Patch.
Device ID | K840262 |
510k Number | K840262 |
Device Name: | HANCOCK PERICARDIAL PATCH |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-19 |
Decision Date | 1984-05-30 |