Device Classification Name |
Drape, Surgical
|
510(k) Number |
K902384 |
Device Name |
ABDOMINAL OR C-SECTION DRAPE SHEET |
Applicant |
MEDICAL PLASTICS, INC. |
1050 NORTHFIELD COURT |
SUITE 300 |
ROSWELL,
GA
30076
|
|
Applicant Contact |
JOSEPH S PRINCE |
Correspondent |
MEDICAL PLASTICS, INC. |
1050 NORTHFIELD COURT |
SUITE 300 |
ROSWELL,
GA
30076
|
|
Correspondent Contact |
JOSEPH S PRINCE |
Regulation Number | 878.4370 |
Classification Product Code |
|
Date Received | 05/30/1990 |
Decision Date | 08/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|