The following data is part of a premarket notification filed by Ranir/dcp Corp. with the FDA for Ranir Dental Tape Mint Waxed With Fluoride.
Device ID | K942690 |
510k Number | K942690 |
Device Name: | RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE |
Classification | Floss, Dental |
Applicant | RANIR/DCP CORP. 4701 EAST PARIS S.E. Grand Rapids, MI 49512 |
Contact | Anne M Armstrong |
Correspondent | Anne M Armstrong RANIR/DCP CORP. 4701 EAST PARIS S.E. Grand Rapids, MI 49512 |
Product Code | JES |
CFR Regulation Number | 872.6390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-07 |
Decision Date | 1995-04-27 |