The following data is part of a premarket notification filed by Rms Div. with the FDA for The Vivacare T.p.s. Probe.
Device ID | K944848 |
510k Number | K944848 |
Device Name: | THE VIVACARE T.P.S. PROBE |
Classification | Probe, Periodontic |
Applicant | RMS DIV. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Lyod V Ziemendorf |
Correspondent | Lyod V Ziemendorf RMS DIV. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EIX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-30 |
Decision Date | 1994-12-14 |