Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K850959 |
Device Name |
EQUIPMENT SNAP KOVERS |
Applicant |
ADVANCE MEDICAL DESIGNS, INC. |
1400 MARIETTA PARKWAY, SU 105 |
MARIETTA,
GA
30067
|
|
Applicant Contact |
JOSEPH R COTTONE |
Correspondent |
ADVANCE MEDICAL DESIGNS, INC. |
1400 MARIETTA PARKWAY, SU 105 |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
JOSEPH R COTTONE |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/08/1985 |
Decision Date | 04/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|