The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Ferris Polymem Sterile Breast Pad.
| Device ID | K031660 |
| 510k Number | K031660 |
| Device Name: | FERRIS POLYMEM STERILE BREAST PAD |
| Classification | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (f-68) |
| Applicant | FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
| Contact | Theodore R Thorsen |
| Correspondent | Theodore R Thorsen FERRIS MFG. CORP. 16W300 83RD ST. Burr Ridge, IL 60527 -5848 |
| Product Code | NTX |
| CFR Regulation Number | 880.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-05-28 |
| Decision Date | 2005-02-22 |