The following data is part of a premarket notification filed by Ranir/dcp Corp. with the FDA for Ranir Hi-technology Dental Floss.
Device ID | K955530 |
510k Number | K955530 |
Device Name: | RANIR HI-TECHNOLOGY DENTAL FLOSS |
Classification | Toothbrush, Manual |
Applicant | RANIR/DCP CORP. 4701 EAST PARIS S.E. Grand Rapids, MI 49512 |
Contact | Anne Armstrong |
Correspondent | Anne Armstrong RANIR/DCP CORP. 4701 EAST PARIS S.E. Grand Rapids, MI 49512 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-04 |
Decision Date | 1995-12-28 |