Device Classification Name |
Dress, Surgical
|
510(k) Number |
K894760 |
Device Name |
CLOTHINGUARD |
Applicant |
BARRIER CONCEPTS, INC. |
POST OFFICE BOX 11421 |
COLUMBIA,
SC
29211
|
|
Applicant Contact |
STEVEN C HASTEROK |
Correspondent |
BARRIER CONCEPTS, INC. |
POST OFFICE BOX 11421 |
COLUMBIA,
SC
29211
|
|
Correspondent Contact |
STEVEN C HASTEROK |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 07/27/1989 |
Decision Date | 08/18/1989 |
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
|
|
|