EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL


Device Classification Name

instrument, surgical, sonic and accessory/attachment

510(k) Number K002484
Device Name EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
Original Applicant
ELECTRO MEDICAL SYSTEMS SA
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer
Regulation Number 888.4580
Classification Product Code
JDX  
Subsequent Product Codes
GET   HSX   LZV  
Date Received 08/14/2000
Decision Date 10/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No