The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Hancock Vascular Graft.
Device ID | K820600 |
510k Number | K820600 |
Device Name: | HANCOCK VASCULAR GRAFT |
Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSY |
CFR Regulation Number | 870.3450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-04 |
Decision Date | 1982-07-08 |