REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE


the company

Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K002987
Device Name REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
Original Applicant
XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216 -0980

Original Contact martin d sargent
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
EQJ  
Date Received 09/25/2000
Decision Date 12/04/2000
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