The following data is part of a premarket notification filed by Oral-b Laboratories with the FDA for Oral-b Flossers.
Device ID | K883024 |
510k Number | K883024 |
Device Name: | ORAL-B FLOSSERS |
Classification | Floss, Dental |
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 | JES |
CFR Regulation Number | 872.6390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-19 |
Decision Date | 1988-08-26 |