Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
|
510(k) Number |
K905073 |
Device Name |
CARDIOVASCULAR REPAIR PATCH |
Applicant |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Applicant Contact |
RAJAGOPAL R KOWLIGI |
Correspondent |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Correspondent Contact |
RAJAGOPAL R KOWLIGI |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 11/09/1990 |
Decision Date | 12/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|