The following data is part of a premarket notification filed by Retinalabs.com with the FDA for Silicone Oil Express (infusion Pak), Models 10000, 10001, 10002, 10003.
| Device ID | K000420 |
| 510k Number | K000420 |
| Device Name: | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Contact | Frank Tighe |
| Correspondent | Frank Tighe RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-05-08 |