The following data is part of a premarket notification filed by Roosin Medical Devices Co., Ltd with the FDA for Roosin Silver Calcium Alginate Dressing (prescription), Roosin Alginate Dressing With Preservative (otc).
| Device ID | K143335 |
| 510k Number | K143335 |
| Device Name: | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing With Preservative (OTC) |
| Classification | Dressing, Wound, Drug |
| Applicant | Roosin Medical Devices Co., Ltd 8 Yuandong Road, KouAn Town, Gaogang Taizhou, CN 225321 |
| Contact | Chengyu Shen |
| Correspondent | Charles Shen Manton Business And Technology Services 853 Dorchester Ln, Unit-B New Milford, NJ 07646 |
| 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 | 2014-11-20 |
| Decision Date | 2015-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856276008762 | K143335 | 000 |
| 00714196525451 | K143335 | 000 |
| 00714196520227 | K143335 | 000 |
| 00714196392145 | K143335 | 000 |
| 00714196392121 | K143335 | 000 |
| 00714196392107 | K143335 | 000 |
| 00714196392084 | K143335 | 000 |
| 00850005565819 | K143335 | 000 |
| 00850005565789 | K143335 | 000 |
| 00850005565765 | K143335 | 000 |
| 00850005565741 | K143335 | 000 |
| 00850005565703 | K143335 | 000 |
| 00850005565253 | K143335 | 000 |
| 00714196530127 | K143335 | 000 |
| 00714196535481 | K143335 | 000 |
| 10856276008700 | K143335 | 000 |
| 10856276008663 | K143335 | 000 |
| 10856276008649 | K143335 | 000 |
| B492205452 | K143335 | 000 |
| B492205442 | K143335 | 000 |
| B492205222 | K143335 | 000 |
| B492205002 | K143335 | 000 |
| 16941094019091 | K143335 | 000 |
| 00714196935144 | K143335 | 000 |
| 00714196935137 | K143335 | 000 |
| 00714196935120 | K143335 | 000 |
| 00714196935113 | K143335 | 000 |
| 00850031608160 | K143335 | 000 |