The following data is part of a premarket notification filed by Piave Spazzolificio S.p.a. with the FDA for Silver Care Anitbacterial Toothbrush.
Device ID | K102871 |
510k Number | K102871 |
Device Name: | SILVER CARE ANITBACTERIAL TOOTHBRUSH |
Classification | Toothbrush, Manual |
Applicant | PIAVE SPAZZOLIFICIO S.P.A. 212 W 91ST ST APT 812 New York, NY 10024 |
Contact | Keila Lacourt |
Correspondent | Keila Lacourt PIAVE SPAZZOLIFICIO S.P.A. 212 W 91ST ST APT 812 New York, NY 10024 |
Product Code | EFW |
CFR Regulation Number | 872.6855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-30 |
Decision Date | 2011-10-03 |