The following data is part of a premarket notification filed by Milliken & Co. with the FDA for Silver Wound Pad.
| Device ID | K083659 |
| 510k Number | K083659 |
| Device Name: | SILVER WOUND PAD |
| Classification | Dressing, Wound, Drug |
| Applicant | MILLIKEN & CO. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane MILLIKEN & CO. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-12-10 |
| Decision Date | 2009-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10015961668647 | K083659 | 000 |
| 00015961668633 | K083659 | 000 |
| 00015961668626 | K083659 | 000 |
| 00015961664147 | K083659 | 000 |
| 10015961293016 | K083659 | 000 |