The following data is part of a premarket notification filed by Hyman, Phelps & Mcnamara, P.c. with the FDA for Prophy Pro..
| Device ID | K945834 |
| 510k Number | K945834 |
| Device Name: | PROPHY PRO. |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | Hyman, Phelps & McNamara, P.C. 700 13TH ST. N.W. STE. 1200 Washington, DC 20005 -5929 |
| Contact | Kenneth A Olsen |
| Correspondent | Kenneth A Olsen Hyman, Phelps & McNamara, P.C. 700 13TH ST. N.W. STE. 1200 Washington, DC 20005 -5929 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-02-13 |