The following data is part of a premarket notification filed by Sagemax Bioceramics, Inc. with the FDA for Nexxzr(tm)t And Nexxzr(tm)s.
Device ID | K130991 |
510k Number | K130991 |
Device Name: | NEXXZR(TM)T AND NEXXZR(TM)S |
Classification | Powder, Porcelain |
Applicant | SAGEMAX BIOCERAMICS, INC. 34210 9th Ave S Suite 118 Federal Way, WA 98003 |
Contact | Jose E Cabrera |
Correspondent | Jose E Cabrera SAGEMAX BIOCERAMICS, INC. 34210 9th Ave S Suite 118 Federal Way, WA 98003 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-10 |
Decision Date | 2014-02-10 |
Summary: | summary |