Device Classification Name |
beads, hydrophilic, for wound exudate absorption
|
510(k) Number |
K904604 |
Device Name |
REDI-RELEASE ABSORBENT DRESSING |
Applicant |
FOUNTAIN PHARMACEUTICALS, INC. |
11201 CONCEPT BLVD. |
SUITE A |
LARGO,
FL
34643
|
|
Applicant Contact |
W FOUNTAIN |
Correspondent |
FOUNTAIN PHARMACEUTICALS, INC. |
11201 CONCEPT BLVD. |
SUITE A |
LARGO,
FL
34643
|
|
Correspondent Contact |
W FOUNTAIN |
Regulation Number | 878.4018
|
Classification Product Code |
|
Date Received | 10/10/1990 |
Decision Date | 01/07/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|