DESARA MESH


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

510(k) Number K112609
Device Name DESARA MESH
Applicant
CALDERA MEDICAL, INC.
5171 clareton drive
agoura hills, 
CA 
91301

Applicant Contact vicki gail
Correspondent
CALDERA MEDICAL, INC.
5171 clareton drive
agoura hills, 
CA 
91301

Correspodent Contact vicki gail
Regulation Number 878.3300
Classification Product Code
OTN  
Date Received 09/08/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No