Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K944879 |
Device Name |
GAUZE SPONGES |
Applicant |
CLINICAL RESOURCES, INC. |
825A TOLLGATE RD. |
ELGIN,
IL
60123
|
|
Applicant Contact |
DAVID INSCO |
Correspondent |
CLINICAL RESOURCES, INC. |
825A TOLLGATE RD. |
ELGIN,
IL
60123
|
|
Correspondent Contact |
DAVID INSCO |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 10/03/1994 |
Decision Date | 12/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|