The following data is part of a premarket notification filed by Alrand, Inc. with the FDA for Alrand Inc. (dental Hand Instruments).
| Device ID | K926190 |
| 510k Number | K926190 |
| Device Name: | ALRAND INC. (DENTAL HAND INSTRUMENTS) |
| Classification | Articulators |
| Applicant | ALRAND, INC. 829 E. PALMETTO PARK RD. Boca Raton, FL 33432 |
| Contact | Alvaro Betancur |
| Correspondent | Alvaro Betancur ALRAND, INC. 829 E. PALMETTO PARK RD. Boca Raton, FL 33432 |
| Product Code | EJP |
| CFR Regulation Number | 872.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-09 |
| Decision Date | 1994-01-18 |