The following data is part of a premarket notification filed by Whitehill Manufacturing, Inc. with the FDA for Reach Stim-u-dent Plaque Removers With Microdent/reach Floss Stiks With Microdent/reach Floss Pics With Microdent Etc..
Device ID | K963747 |
510k Number | K963747 |
Device Name: | REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. |
Classification | Pick, Massaging |
Applicant | WHITEHILL MANUFACTURING, INC. 950 HWY. 36 Hazlet, NJ 07730 |
Contact | Peter P Walters |
Correspondent | Peter P Walters WHITEHILL MANUFACTURING, INC. 950 HWY. 36 Hazlet, NJ 07730 |
Product Code | JET |
CFR Regulation Number | 872.6650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-17 |
Decision Date | 1996-12-16 |