GYNE IDEAS MINITAPE RP DEVICE


Device Classification Name

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

510(k) Number K023898
Device Name GYNE IDEAS MINITAPE RP DEVICE
Original Applicant
GYNE IDEAS LTD.
150 aran hill rd.
fairfield, 
CT 
06824

Original Contact louis mazzarese
Regulation Number 878.3300
Classification Product Code
PAH  
Date Received 11/22/2002
Decision Date 06/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No