REPROCESSED HAND ACTIVATE SEALER/DIVIDER


Device Classification Name

electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed

510(k) Number K111600
Device Name REPROCESSED HAND ACTIVATE SEALER/DIVIDER
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 south 51st st.
phoenix, 
AZ 
85044

Applicant Contact ramona kulik
Correspondent
ASCENT HEALTHCARE SOLUTIONS
10232 south 51st st.
phoenix, 
AZ 
85044

Correspodent Contact ramona kulik
Regulation Number 878.4400
Classification Product Code
NUJ  
Date Received 06/08/2011
Decision Date 11/15/2011
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