Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K944468 |
Device Name |
KERLIX ZINC SALINE DRESSING |
Applicant |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
DAVID A P;SPM |
Correspondent |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
DAVID A P;SPM |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 09/09/1994 |
Decision Date | 11/29/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|