MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX


Device Classification Name

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

510(k) Number K030460
Device Name MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
Applicant
BRENNEN MEDICAL, INC.
1290 hammond rd.
st. paul, 
MN 
55110

Applicant Contact kenneth b herland
Correspondent
BRENNEN MEDICAL, INC.
1290 hammond rd.
st. paul, 
MN 
55110

Correspodent Contact kenneth b herland
Regulation Number 878.3300
Classification Product Code
PAG  
Date Received 02/12/2003
Decision Date 03/07/2003
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