Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K935783 |
Device Name |
MITRAFLEX CAVITY WOUND DRESSING |
Applicant |
POLYMEDICA INDUSTRIES, INC. |
581 CONFERENCE PL. |
GOLDEN,
CO
80401
|
|
Applicant Contact |
ANDREW M REED, PH.D. |
Correspondent |
POLYMEDICA INDUSTRIES, INC. |
581 CONFERENCE PL. |
GOLDEN,
CO
80401
|
|
Correspondent Contact |
ANDREW M REED, PH.D. |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 12/06/1993 |
Decision Date | 02/04/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|