KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K110462
Device Name KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
Applicant
KEPLER MEDTEC
200 homer ave
ashland, 
MA 
01721

Applicant Contact sharyn orton, phd
Correspondent
KEPLER MEDTEC
200 homer ave
ashland, 
MA 
01721

Correspodent Contact sharyn orton, phd
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/17/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No