Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K922054 |
Device Name |
STERILE GAUZE SPONGES X-RAY DETECTABLE |
Applicant |
TEAM MFG., INC. |
P.O. BOX 15427 |
AUGUSTA,
GA
30919
|
|
Applicant Contact |
NORRIS R HAROD |
Correspondent |
TEAM MFG., INC. |
P.O. BOX 15427 |
AUGUSTA,
GA
30919
|
|
Correspondent Contact |
NORRIS R HAROD |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 05/04/1992 |
Decision Date | 08/10/1992 |
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
|