The following data is part of a premarket notification filed by Entravision, Inc. with the FDA for Entravision Modeco Ii I/a Machine & I/a Handpiece.
| Device ID | K862063 |
| 510k Number | K862063 |
| Device Name: | ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE |
| Classification | Unit, Phacofragmentation |
| Applicant | ENTRAVISION, INC. 641 NUWAY CIRCLE P.O. BOX 1738 Lenoir, NC 28645 |
| Contact | Newton, R.n. |
| Correspondent | Newton, R.n. ENTRAVISION, INC. 641 NUWAY CIRCLE P.O. BOX 1738 Lenoir, NC 28645 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-06-19 |