DESARA MINI


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

510(k) Number K103418
Device Name DESARA MINI
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
PAH  
Date Received 11/22/2010
Decision Date 11/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No