Device Classification Name |
system, vocal cord medialization
|
510(k) Number |
K071663 |
Device Name |
VF GEL PLUS |
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 | 874.3620
|
Classification Product Code |
|
Date Received | 06/18/2007 |
Decision Date | 02/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|