BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818


Device Classification Name

biopsy needle kit

510(k) Number K081323
Device Name BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
Applicant
B-K MEDICAL APS
mileparken 34
herlev, 

DK

dk-2730

Applicant Contact jens rasmussen
Correspondent
B-K MEDICAL APS
mileparken 34
herlev, 

DK

dk-2730

Correspodent Contact jens rasmussen
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 05/12/2008
Decision Date 07/22/2008
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