The following data is part of a premarket notification filed by Dalim Tissen Co., Ltd. with the FDA for Collagen Wound Dressing.
| Device ID | K112580 |
| 510k Number | K112580 |
| Device Name: | COLLAGEN WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | DALIM TISSEN CO., LTD. 325 N PUENTE STREET UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee DALIM TISSEN CO., LTD. 325 N PUENTE STREET UNIT B Brea, CA 92821 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2012-06-01 |
| Summary: | summary |