BOSTON SCIENTIFIC SURGICAL MESH


Device Classification Name

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

510(k) Number K081275
Device Name BOSTON SCIENTIFIC SURGICAL MESH
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact janet a mcgrath
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact janet a mcgrath
Regulation Number 878.3300
Classification Product Code
PAH  
Date Received 05/05/2008
Decision Date 08/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No