The following data is part of a premarket notification filed by Milliken Healthcare Products, Llc with the FDA for Ultra Silver Dressings.
| Device ID | K141603 |
| 510k Number | K141603 |
| Device Name: | Ultra Silver Dressings |
| Classification | Dressing, Wound, Drug |
| Applicant | MILLIKEN HEALTHCARE PRODUCTS, LLC 62 FOREST STREET,SUITE300 Marlborough, MA 01752 |
| Contact | Gordon Macfarlane |
| Correspondent | Gordon Macfarlane MILLIKEN HEALTHCARE PRODUCTS, LLC 62 FOREST STREET,SUITE300 Marlborough, MA 01752 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-06-16 |
| Decision Date | 2014-10-22 |
| Summary: | summary |