Device Classification Name |
arthroscope
|
510(k) Number |
K141557 |
Device Name |
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR |
Applicant |
GALLINI MEDICAL DEVICES, SRL |
1531 FELTON ROAD |
SOUTH EUCLID,
OH
44121
|
|
Applicant Contact |
ARTHUR S GODDARD |
Correspondent |
GALLINI MEDICAL DEVICES, SRL |
1531 FELTON ROAD |
SOUTH EUCLID,
OH
44121
|
|
Correspondent Contact |
ARTHUR S GODDARD |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 06/12/2014 |
Decision Date | 12/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|