BIPOLAR HF DEVICE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K110695
Device Name BIPOLAR HF DEVICE
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact lisa m boyle
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact lisa m boyle
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 03/14/2011
Decision Date 06/28/2011
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