Device Classification Name |
instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
|
510(k) Number |
K991588 |
Device Name |
EMS SWISS ORTHOCLAST |
Applicant |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
SHEILA HAMEON-HEYER |
Correspondent |
(EMS SA) ELECTRO MEDICAL SYSTEMS |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
SHEILA HAMEON-HEYER |
Regulation Number | 878.4820
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/07/1999 |
Decision Date | 07/21/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|