Device Classification Name |
dressing, wound and burn, hydrogel w/drug and/or biologic
|
510(k) Number |
K042722 |
Device Name |
ALOCLAIR ORAL SPRAY |
Applicant |
SINCLAIR PHARMACEUTICALS, LTD. |
BOROUGH RD. |
GODALMING, SURREY,
GB
GU7 2AB
|
|
Applicant Contact |
MICHAEL KILLEEN |
Correspondent |
SINCLAIR PHARMACEUTICALS, LTD. |
BOROUGH RD. |
GODALMING, SURREY,
GB
GU7 2AB
|
|
Correspondent Contact |
MICHAEL KILLEEN |
Classification Product Code |
|
Date Received | 10/01/2004 |
Decision Date | 01/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|