DESARA MESH SLING, MODEL CAL-DS01


Device Classification Name

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

510(k) Number K072456
Device Name DESARA MESH SLING, MODEL CAL-DS01
Applicant
CALDERA MEDICAL, INC.
1205 de la vina
santa barbara, 
CA 
93101

Applicant Contact christine emanuel
Correspondent
CALDERA MEDICAL, INC.
1205 de la vina
santa barbara, 
CA 
93101

Correspodent Contact christine emanuel
Regulation Number 878.3300
Classification Product Code
OTN  
Date Received 08/31/2007
Decision Date 05/08/2008
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