The following data is part of a premarket notification filed by Oral-b Laboratories with the FDA for Oral-b Interdental Woodsticks With Fluoride.
Device ID | K942633 |
510k Number | K942633 |
Device Name: | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE |
Classification | Pick, Massaging |
Applicant | ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
Contact | Sharon Snyder |
Correspondent | Sharon Snyder ORAL-B LABORATORIES ONE LAGOON DR. Redwood City, CA 94065 |
Product Code | JET |
CFR Regulation Number | 872.6650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-03 |
Decision Date | 1995-04-27 |
Summary: | summary |