Device Classification Name |
Wound Dressing Kit
|
510(k) Number |
K923905 |
Device Name |
WOUND DRESSING KIT |
Applicant |
KIT PAK, INC. |
825 CHASE AVE. |
ELK GROVE VILLAGE,
IL
60007
|
|
Applicant Contact |
THOMAS SANDERS |
Correspondent |
KIT PAK, INC. |
825 CHASE AVE. |
ELK GROVE VILLAGE,
IL
60007
|
|
Correspondent Contact |
THOMAS SANDERS |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 08/04/1992 |
Decision Date | 07/02/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|