The following data is part of a premarket notification filed by Entravision, Inc. with the FDA for Entravision Modeco Ii Vitreous Cutting Handpiece.
| Device ID | K870775 |
| 510k Number | K870775 |
| Device Name: | ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ENTRAVISION, INC. 641 NUWAY CIRCLE P.O. BOX 1738 Lenoir, NC 28645 |
| Contact | Newton, Rn |
| Correspondent | Newton, Rn ENTRAVISION, INC. 641 NUWAY CIRCLE P.O. BOX 1738 Lenoir, NC 28645 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-03-26 |