The following data is part of a premarket notification filed by Megagen Co., Ltd. with the FDA for Rescue Internal Implant System.
| Device ID | K063216 |
| 510k Number | K063216 |
| Device Name: | RESCUE INTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Sun Hahm |
| Correspondent | Sun Hahm MEGAGEN CO., LTD. 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2007-04-02 |
| Summary: | summary |