MODIFICATION TO VF GEL PLUS


Device Classification Name

system, vocal cord medialization

510(k) Number K080956
Device Name MODIFICATION TO 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

Correspodent Contact linda ruedy
Regulation Number 874.3620
Classification Product Code
MIX  
Date Received 04/03/2008
Decision Date 04/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No