The following data is part of a premarket notification filed by Ocutec Corporation, Inc. with the FDA for Novalens/novawet Perception And Vanguard.
| Device ID | K942533 |
| 510k Number | K942533 |
| Device Name: | NOVALENS/NOVAWET PERCEPTION AND VANGUARD |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | OCUTEC CORPORATION, INC. 2700-200 GATEWAY CENTER BLVD. Morrisville, NC 27560 |
| Contact | Alan J Touch |
| Correspondent | Alan J Touch OCUTEC CORPORATION, INC. 2700-200 GATEWAY CENTER BLVD. Morrisville, NC 27560 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1994-08-05 |