• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
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 Number878.3300
Classification Product Code
OTN  
Date Received09/08/2011
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
-
-