Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K971612 |
Device Name |
OSMO/PCA PILLOW WOUND DRESSING |
Applicant |
PROCYTE CORP. |
12040 115TH AVENUE NE |
SUITE 210 |
KIRKLAND,
WA
98034 -6900
|
|
Applicant Contact |
PAUL KETTERIDGE |
Correspondent |
PROCYTE CORP. |
12040 115TH AVENUE NE |
SUITE 210 |
KIRKLAND,
WA
98034 -6900
|
|
Correspondent Contact |
PAUL KETTERIDGE |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 05/02/1997 |
Decision Date | 03/16/1998 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|