The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co, Ltd with the FDA for Suntouch Topical Hemostatic Dressing.
| Device ID | K112800 |
| 510k Number | K112800 |
| Device Name: | SUNTOUCH TOPICAL HEMOSTATIC DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington, NJ 08534 |
| Contact | Chengyu Shen |
| Correspondent | Chengyu Shen HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington, NJ 08534 |
| 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 | 2011-09-27 |
| Decision Date | 2012-05-23 |
| Summary: | summary |