The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Polymem Calcium Alginate Sterile Wound Dressing.
| Device ID | K984539 |
| 510k Number | K984539 |
| Device Name: | FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | FERRIS MFG. CORP. 16 WEST 300 83RD ST. Burr Ridge, IL 60527 |
| Contact | Theodore Thorsen |
| Correspondent | Theodore Thorsen FERRIS MFG. CORP. 16 WEST 300 83RD ST. Burr Ridge, IL 60527 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-03-01 |