Device Classification Name |
Bandage, Liquid
|
510(k) Number |
K971090 |
Device Name |
OPPORTUNITY DRESSING CHANGE TRAY |
Applicant |
OPPORTUNITY, INC. |
1200 OLD SKOKIE RD. |
HIGHLAND PARK,
IL
60035
|
|
Applicant Contact |
JAMES S SANDERS |
Correspondent |
OPPORTUNITY, INC. |
1200 OLD SKOKIE RD. |
HIGHLAND PARK,
IL
60035
|
|
Correspondent Contact |
JAMES S SANDERS |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 03/24/1997 |
Decision Date | 09/16/1997 |
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
|
|
|