Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K953830 |
Device Name |
KENSORB |
Applicant |
KENTRON HEALTH CARE, INC. |
4330 SHERIDAN ST. |
HOLLYWOOD,
FL
33021
|
|
Applicant Contact |
NARI SADARANGANI |
Correspondent |
KENTRON HEALTH CARE, INC. |
4330 SHERIDAN ST. |
HOLLYWOOD,
FL
33021
|
|
Correspondent Contact |
NARI SADARANGANI |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 08/16/1995 |
Decision Date | 10/03/1995 |
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
|
|
|