BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR


information about

Device Classification Name

protector, transducer, dialysis

510(k) Number K000702
Device Name BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
Original Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
two ledgemont center
95 hayden avenue
lexington, 
MA 
02420

Original Contact arthur eilinsfeld
Regulation Number 876.5820
Classification Product Code
FIB  
Subsequent Product Code
FJK  
Date Received 03/01/2000
Decision Date 06/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No