INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL


Device Classification Name

instrument, biopsy

510(k) Number K081057
Device Name INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
Applicant
INTACT MEDICAL CORPORATION
one apple hill suite 316
natick, 
MA 
01760

Applicant Contact douglas macarthur
Correspondent
INTACT MEDICAL CORPORATION
one apple hill suite 316
natick, 
MA 
01760

Correspodent Contact douglas macarthur
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 04/14/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No