Device Classification Name |
material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
|
510(k) Number |
K951474 |
Device Name |
TLC SURGICAL DRAPES |
Applicant |
TLC TECH LAB CLOTHES, INC. |
2875 LEON ST. |
MUSKEGON,
MI
49441
|
|
Applicant Contact |
DAWN ERICKSON-STEVENS |
Correspondent |
TLC TECH LAB CLOTHES, INC. |
2875 LEON ST. |
MUSKEGON,
MI
49441
|
|
Correspondent Contact |
DAWN ERICKSON-STEVENS |
Regulation Number | 878.3500
|
Classification Product Code |
|
Date Received | 03/30/1995 |
Decision Date | 08/18/1995 |
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
|
|
|