Device Classification Name |
Drape, Surgical
|
510(k) Number |
K850199 |
Device Name |
POLY-LINED TOWEL/DRAPE LINE |
Applicant |
EXCEL HEALTH CARE PRODUCTS |
5001 HADLEY RD. |
SOUTH PLAINFIELD,
NJ
07080
|
|
Applicant Contact |
DAVID CATLIN |
Correspondent |
EXCEL HEALTH CARE PRODUCTS |
5001 HADLEY RD. |
SOUTH PLAINFIELD,
NJ
07080
|
|
Correspondent Contact |
DAVID CATLIN |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 01/18/1985 |
Decision Date | 02/21/1985 |
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
|
Recalls |
CDRH Recalls
|
|
|