Device Classification Name |
holder, syringe, lead
|
510(k) Number |
K811688 |
Device Name |
TUNGSTEN SYRINGE SHIELD |
Applicant |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 892.6500
|
Classification Product Code |
|
Date Received | 06/15/1981 |
Decision Date | 07/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|