Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K905022 |
Device Name |
AQUA-GARD WATERPROOF WOUND PATCH |
Applicant |
BELLHOUSE MEDICAL, INC. |
2933 MANNING AVENUE NORTH |
LAKE ELMO,
MN
55042
|
|
Applicant Contact |
JULIA LORD |
Correspondent |
BELLHOUSE MEDICAL, INC. |
2933 MANNING AVENUE NORTH |
LAKE ELMO,
MN
55042
|
|
Correspondent Contact |
JULIA LORD |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 11/07/1990 |
Decision Date | 02/11/1991 |
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
|
|
|