| Device Classification Name |
Bandage, Liquid
|
| 510(k) Number |
K932913 |
| Device Name |
FERRIS POLYMEM HYDROPHILIC WOUND DRESSING |
| Applicant |
| Ferris Mfg. Corp. |
| 16 W. 300 83rd St. |
|
Burr Ridge,
IL
60527
|
|
| Applicant Contact |
JEFFREY A DZIURA |
| Correspondent |
| Ferris Mfg. Corp. |
| 16 W. 300 83rd St. |
|
Burr Ridge,
IL
60527
|
|
| Correspondent Contact |
JEFFREY A DZIURA |
| Regulation Number | 880.5090 |
| Classification Product Code |
|
| Date Received | 06/16/1993 |
| Decision Date | 06/07/1994 |
| 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
|
Predetermined Change Control Plan Authorized |
No
|
|
|