Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K051415 |
Device Name |
ENDOTINE RIBBON |
Applicant |
COAPT SYSTEMS, INC. |
1820 EMBARCADERO RD. |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
LINDA RUEDY |
Correspondent |
COAPT SYSTEMS, INC. |
1820 EMBARCADERO RD. |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
LINDA RUEDY |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 06/01/2005 |
Decision Date | 06/23/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|