Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K941344 |
Device Name |
LAP SPONGE PRODUCT LINE |
Applicant |
CUSH MEDICAL PRODUCTS |
881 MOUNTAIN VIEW DR. |
PINEY FLATS,
TN
37686
|
|
Applicant Contact |
STEVE B JOHNSTON |
Correspondent |
CUSH MEDICAL PRODUCTS |
881 MOUNTAIN VIEW DR. |
PINEY FLATS,
TN
37686
|
|
Correspondent Contact |
STEVE B JOHNSTON |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 03/17/1994 |
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
|