Device Classification Name |
bandage, liquid
|
510(k) Number |
K951730 |
Device Name |
SPYROFOAM WOUND DRESSING |
Applicant |
POLYMEDICA INDUSTRIES, INC. |
581 CONFERENCE PLACE |
GOLDEN,
CO
80401
|
|
Applicant Contact |
ANDREW M REED |
Correspondent |
POLYMEDICA INDUSTRIES, INC. |
581 CONFERENCE PLACE |
GOLDEN,
CO
80401
|
|
Correspondent Contact |
ANDREW M REED |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 04/14/1995 |
Decision Date | 06/16/1995 |
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
|
|
|