The following data is part of a premarket notification filed by Leonard Lorch with the FDA for Floss N' Gloss/safety Floss Med Device.
Device ID | K841675 |
510k Number | K841675 |
Device Name: | FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE |
Classification | Floss, Dental |
Applicant | LEONARD LORCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JES |
CFR Regulation Number | 872.6390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-06-27 |