The following data is part of a premarket notification filed by Megagen Implant Co., Ltd with the FDA for Rescue External Implant System.
| Device ID | K081302 |
| 510k Number | K081302 |
| Device Name: | RESCUE EXTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEGAGEN IMPLANT CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Jung B Bang |
| Correspondent | Jung B Bang MEGAGEN IMPLANT 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 | 2008-05-08 |
| Decision Date | 2008-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806388233205 | K081302 | 000 |
| 08806388225293 | K081302 | 000 |
| 08806388225279 | K081302 | 000 |
| 08806388225255 | K081302 | 000 |
| 08806388225231 | K081302 | 000 |
| 08806388225101 | K081302 | 000 |
| 08806388225095 | K081302 | 000 |
| 08806388225088 | K081302 | 000 |
| 08806388225071 | K081302 | 000 |
| 08806388225316 | K081302 | 000 |
| 08806388225330 | K081302 | 000 |
| 08806388233182 | K081302 | 000 |
| 08806388233168 | K081302 | 000 |
| 08806388233144 | K081302 | 000 |
| 08806388233120 | K081302 | 000 |
| 08806388233106 | K081302 | 000 |
| 08806388233083 | K081302 | 000 |
| 08806388225385 | K081302 | 000 |
| 08806388225361 | K081302 | 000 |
| 08809931185846 | K081302 | 000 |