Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K032698 |
Device Name |
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE |
Applicant |
COAPT SYSTEMS, INC. |
1820 EMBARCADERO RD. |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
LORI DONDIEGO |
Correspondent |
COAPT SYSTEMS, INC. |
1820 EMBARCADERO RD. |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
LORI DONDIEGO |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/02/2003 |
Decision Date | 10/23/2003 |
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
|
|
|