Device Classification Name |
bandage, liquid
|
510(k) Number |
K921502 |
Device Name |
HYSORB WOUND DRESSING |
Applicant |
KINGSTON TECHNOLOGIES, INC. |
2235 ROUTE 130 |
DAYTON,
NJ
08810
|
|
Applicant Contact |
KENNETH BLASHKA |
Correspondent |
KINGSTON TECHNOLOGIES, INC. |
2235 ROUTE 130 |
DAYTON,
NJ
08810
|
|
Correspondent Contact |
KENNETH BLASHKA |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 03/31/1992 |
Decision Date | 09/29/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|