The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Sterile Ns System.
| Device ID | K170368 |
| 510k Number | K170368 |
| Device Name: | Sterile NS System |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | Jeil Medical Corporation 55 Digital-ro, 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul, KR 152-728 |
| Contact | Seungyong Lee |
| Correspondent | Ji Won Song Jeil Medical Corporation 55 Digital-ro, 34-gil 702, 703, 704, 705, 706, 804, 805, 807, 812-ho Seoul, KR 152-728 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806390855228 | K170368 | 000 |
| 08806390854658 | K170368 | 000 |
| 08806390855150 | K170368 | 000 |
| 08806390855167 | K170368 | 000 |
| 08806390855174 | K170368 | 000 |
| 08806390855181 | K170368 | 000 |
| 08806390855198 | K170368 | 000 |
| 08806390855204 | K170368 | 000 |
| 08806390855211 | K170368 | 000 |
| 08806390854641 | K170368 | 000 |