Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K991609 |
Device Name |
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING |
Applicant |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN. |
ARVADA,
CO
80005 -5306
|
|
Applicant Contact |
ANDREW M REED |
Correspondent |
DERMAPHYLYX, INC. |
12106, WEST 75TH LN. |
ARVADA,
CO
80005 -5306
|
|
Correspondent Contact |
ANDREW M REED |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 05/10/1999 |
Decision Date | 07/20/1999 |
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
|
|
|