Device Classification Name |
bandage, liquid
|
510(k) Number |
K030574 |
Device Name |
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER |
Applicant |
GLUSTITCH, INC. |
#307 7188 PROGRESS WAY |
DELTA, B.C.,
CA
V4G 1M6
|
|
Applicant Contact |
DON BLACKLOCK |
Correspondent |
GLUSTITCH, INC. |
#307 7188 PROGRESS WAY |
DELTA, B.C.,
CA
V4G 1M6
|
|
Correspondent Contact |
DON BLACKLOCK |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 02/24/2003 |
Decision Date | 08/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|