Device Classification Name |
Gauze / Sponge,Nonresorbable For External Use
|
510(k) Number |
K914937 |
Device Name |
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES |
Applicant |
KERMA MEDICAL PRODUCTS, INC. |
1801-P SARA DR. |
CHESAPEAKE,
VA
23320
|
|
Applicant Contact |
BESSIE N TODD |
Correspondent |
KERMA MEDICAL PRODUCTS, INC. |
1801-P SARA DR. |
CHESAPEAKE,
VA
23320
|
|
Correspondent Contact |
BESSIE N TODD |
Regulation Number | 878.4014
|
Classification Product Code |
|
Date Received | 11/04/1991 |
Decision Date | 12/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|