The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Speedy Flap System.
| Device ID | K130447 |
| 510k Number | K130447 |
| Device Name: | SPEEDY FLAP SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Jeil Medical Corporation #702, Kolon Science Valley 2nd 811, Guro-Dong, Guro-Gu Seoul, KR 152-050 |
| Contact | Jieun Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2014-12-22 |
| Summary: | summary |