The following data is part of a premarket notification filed by Rand Scientific Corp. with the FDA for Pmma Clasic.
| Device ID | K955777 |
| 510k Number | K955777 |
| Device Name: | PMMA CLASIC |
| Classification | Lens, Contact (polymethylmethacrylate) |
| Applicant | RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD. SUITE 9 Sacramento, CA 95834 |
| Contact | Duane Tracy |
| Correspondent | Duane Tracy RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD. SUITE 9 Sacramento, CA 95834 |
| Product Code | HPX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-20 |
| Decision Date | 1996-05-16 |
| Summary: | summary |