The following data is part of a premarket notification filed by Luneau Sa with the FDA for Luneau Sterile Tonometer Separation Prisms.
| Device ID | K023838 |
| 510k Number | K023838 |
| Device Name: | LUNEAU STERILE TONOMETER SEPARATION PRISMS |
| Classification | Tonometer, Manual |
| Applicant | LUNEAU SA BP 252 Chartres Cedex, FR 28005 |
| Contact | Jean N Young |
| Correspondent | Jean N Young LUNEAU SA BP 252 Chartres Cedex, FR 28005 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2003-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664188000114 | K023838 | 000 |
| 03664188000107 | K023838 | 000 |