KSEA POWERSHAVER SYSTEM S2


Device Classification Name

arthroscope

510(k) Number K030009
Device Name KSEA POWERSHAVER SYSTEM S2
Original Applicant
KARL STORZ ENDOSCOPY
600 corporate pointe
culver city, 
CA 
90230 -7600

Original Contact renate a maclaren
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 01/02/2003
Decision Date 04/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No