HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K024138
Device Name HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact tina steffanic-oak
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 12/16/2002
Decision Date 03/12/2003
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