The following data is part of a premarket notification filed by Curaline Inc with the FDA for Curaline Polyurethane Foam Awc Dressing.
| Device ID | K121361 |
| 510k Number | K121361 |
| Device Name: | CURALINE POLYURETHANE FOAM AWC DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | CURALINE INC 10554 NORTH WASHINGTON PORT ROAD Mequon, WI 53092 |
| Contact | Haitham Matloub |
| Correspondent | Haitham Matloub CURALINE INC 10554 NORTH WASHINGTON PORT ROAD Mequon, WI 53092 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-11-30 |
| Summary: | summary |