The following data is part of a premarket notification filed by Envision Advanced Medical System Ltd with the FDA for Elran 01 System.
| Device ID | K002431 |
| 510k Number | K002431 |
| Device Name: | ELRAN 01 SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENVISION ADVANCED MEDICAL SYSTEM LTD 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Gerard J Prud'homme |
| Correspondent | Gerard J Prud'homme ENVISION ADVANCED MEDICAL SYSTEM LTD 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-10-24 |