Device Classification Name |
Drape, Surgical
|
510(k) Number |
K761204 |
Device Name |
BARRIER IMPERVIOUS BACK TABLE COVER |
Applicant |
SURGIKOS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SURGIKOS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 12/07/1976 |
Decision Date | 01/12/1977 |
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
|
|
|