The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Polymem Sterile Wound Dressing With Collagen.
| Device ID | K002129 |
| 510k Number | K002129 |
| Device Name: | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | FERRIS MFG. CORP. 16 W. 300 83RD ST. Burr Ridge, IL 60521 |
| Contact | Theodore Thorsen |
| Correspondent | Theodore Thorsen FERRIS MFG. CORP. 16 W. 300 83RD ST. Burr Ridge, IL 60521 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2000-08-25 |