SURGITRON IEC II


codes

Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K001253
Device Name SURGITRON IEC II
Original Applicant
ELLMAN INTL., INC.
1135 railroad ave.,
ellman bldg.
hewlett, 
NY 
11557

Original Contact frank lin
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 04/19/2000
Decision Date 05/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No