Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K941522 |
Device Name |
STERILE X-RAY DETECTABLE GAUZE SPONGES |
Applicant |
CUSH MEDICAL PRODUCTS |
P.O. BOX 247 |
881 MOUNTAIN VIEW DRIVE |
PINEY FLATS,
TN
37686
|
|
Applicant Contact |
STEVE B JOHNSON |
Correspondent |
CUSH MEDICAL PRODUCTS |
P.O. BOX 247 |
881 MOUNTAIN VIEW DRIVE |
PINEY FLATS,
TN
37686
|
|
Correspondent Contact |
STEVE B JOHNSON |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 03/30/1994 |
Decision Date | 05/12/1994 |
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
|