The following data is part of a premarket notification filed by The Lahr Consulting Group, Inc. with the FDA for Mani Dia-burs.
| Device ID | K913651 |
| 510k Number | K913651 |
| Device Name: | MANI DIA-BURS |
| Classification | Instrument, Diamond, Dental |
| Applicant | THE LAHR CONSULTING GROUP, INC. ONE LETHBRIDGE PLAZA SUITE #4 Mahwah, NJ 07430 -2113 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly THE LAHR CONSULTING GROUP, INC. ONE LETHBRIDGE PLAZA SUITE #4 Mahwah, NJ 07430 -2113 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-16 |
| Decision Date | 1992-01-14 |