The following data is part of a premarket notification filed by Periodontal Health Brush, Inc. with the FDA for Disposable Periodontal Probe.
Device ID | K871504 |
510k Number | K871504 |
Device Name: | DISPOSABLE PERIODONTAL PROBE |
Classification | Probe, Periodontic |
Applicant | PERIODONTAL HEALTH BRUSH, INC. BOX 101, R3 HIGHWAY 53 Osseo, WI 54758 |
Contact | Jeffrey Novak |
Correspondent | Jeffrey Novak PERIODONTAL HEALTH BRUSH, INC. BOX 101, R3 HIGHWAY 53 Osseo, WI 54758 |
Product Code | EIX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-17 |
Decision Date | 1987-05-06 |