MINITAPE EXTRA URETHRAL SLING


Device Classification Name

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

510(k) Number K073647
Device Name MINITAPE EXTRA URETHRAL SLING
Applicant
MPATHY MEDICAL DEVICES, LTD.
24 barberry lane
madison, 
CT 
06443

Applicant Contact louis j mazzarese
Correspondent
MPATHY MEDICAL DEVICES, LTD.
24 barberry lane
madison, 
CT 
06443

Correspodent Contact louis j mazzarese
Regulation Number 878.3300
Classification Product Code
OTN  
Date Received 12/26/2007
Decision Date 03/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No