Device Classification Name |
patch, pledget and intracardiac, petp, ptfe, polypropylene
|
510(k) Number |
K200566 |
Device Name |
ADAPT Tissue |
Applicant |
Admedus Regen Pty Ltd |
26 Harris Road |
Malaga,
AU
6080
|
|
Applicant Contact |
Kiran Bhirangi |
Correspondent |
Admedus Regen Pty Ltd |
860 Blue Gentian Road, Suite 340 |
Eagan,
MN
55121
|
|
Correspondent Contact |
Diana Upp |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 03/04/2020 |
Decision Date | 04/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|