LITE PELVIC FLOOR REPAIR KITS


Device Classification Name

mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed

510(k) Number K103426
Device Name LITE PELVIC FLOOR REPAIR KITS
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact michelle berry
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact michelle berry
Regulation Number 878.3300
Classification Product Code
OTP  
Date Received 11/22/2010
Decision Date 09/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No