MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-


Device Classification Name

instrument, biopsy

510(k) Number K111529
Device Name MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
Applicant
INSERT MOLDING SOLUTIONS, INC
4325 settingdown circle
suite 103
cumming, 
GA 
30028

Applicant Contact paul hendrixson
Correspondent
INSERT MOLDING SOLUTIONS, INC
4325 settingdown circle
suite 103
cumming, 
GA 
30028

Correspodent Contact paul hendrixson
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 06/02/2011
Decision Date 07/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No