The following data is part of a premarket notification filed by Teledyne, Inc. with the FDA for Oraview By Water Pik.
Device ID | K800919 |
510k Number | K800919 |
Device Name: | ORAVIEW BY WATER PIK |
Classification | Mirror, Mouth |
Applicant | TELEDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-21 |
Decision Date | 1980-05-08 |