Device Classification Name |
material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
|
510(k) Number |
K781019 |
Device Name |
SURG. GOWN & DRAPE, LOW LINT TREATMENT |
Applicant |
KIMBERLY-CLARK CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KIMBERLY-CLARK CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.3500
|
Classification Product Code |
|
Date Received | 01/16/1978 |
Decision Date | 08/14/1978 |
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
|