The following data is part of a premarket notification filed by Ophtec Usa, Inc. with the FDA for Easy Control Micro Inserter, Model On385.
| Device ID | K011498 |
| 510k Number | K011498 |
| Device Name: | EASY CONTROL MICRO INSERTER, MODEL ON385 |
| Classification | Injector, Capsular Tension Ring |
| Applicant | OPHTEC USA, INC. 6421 CONGRESS AVE., SUITE 112 Boca Raton, FL 33487 |
| Contact | Rick Mccarley |
| Correspondent | Rick Mccarley OPHTEC USA, INC. 6421 CONGRESS AVE., SUITE 112 Boca Raton, FL 33487 |
| Product Code | NCE |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2001-07-09 |