The following data is part of a premarket notification filed by Solco Biomedical Co., Ltd. with the FDA for Solco 4cis General Plate System.
| Device ID | K051155 |
| 510k Number | K051155 |
| Device Name: | SOLCO 4CIS GENERAL PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817 |
| Contact | Saeyoung Ahn |
| Correspondent | Saeyoung Ahn SOLCO BIOMEDICAL CO., LTD. 7612 BARNUM ROAD Bethesda, MD 20817 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2005-07-11 |
| Summary: | summary |