The following data is part of a premarket notification filed by Roosin Medical Co., Ltd with the FDA for Roosin Xeroform Petrolatum Dressing.
| Device ID | K181478 |
| 510k Number | K181478 |
| Device Name: | Roosin Xeroform Petrolatum Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Roosin Medical Co., Ltd 8 Yuandong Road, KouAn Town, Gaogang Taizhou, CN 225321 |
| Contact | Charles Shen |
| Correspondent | Charles Shen Manton Business And Technology Services LLC 37 Winding Ridge Oakland, NJ 07436 |
| 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 | 2018-06-05 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26958868747002 | K181478 | 000 |
| 10810113578092 | K181478 | 000 |
| 10810113578108 | K181478 | 000 |
| 10810113578115 | K181478 | 000 |
| 26958868747040 | K181478 | 000 |
| 26958868747057 | K181478 | 000 |
| 26958868747064 | K181478 | 000 |
| 26958868747071 | K181478 | 000 |
| 26958868747019 | K181478 | 000 |
| 10810113578085 | K181478 | 000 |