The following data is part of a premarket notification filed by Milliken Healthcare Products, Llc with the FDA for Low Adherent Afm Ag Dressings.
| Device ID | K103141 |
| 510k Number | K103141 |
| Device Name: | LOW ADHERENT AFM AG DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | MILLIKEN HEALTHCARE PRODUCTS, LLC 11440 W. BERNARDO COURT SUITE 300 San Diego, CA 92127 |
| Contact | Ronald S Warren, Rac |
| Correspondent | Ronald S Warren, Rac MILLIKEN HEALTHCARE PRODUCTS, LLC 11440 W. BERNARDO COURT SUITE 300 San Diego, CA 92127 |
| 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 | 2010-10-25 |
| Decision Date | 2011-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015961681519 | K103141 | 000 |
| 10015961681509 | K103141 | 000 |
| 00015961681496 | K103141 | 000 |
| 00015961464396 | K103141 | 000 |
| 00015961464365 | K103141 | 000 |
| 10015961464355 | K103141 | 000 |