The following data is part of a premarket notification filed by Neirynck & Vogt Nv with the FDA for Ceraloy.
Device ID | K021971 |
510k Number | K021971 |
Device Name: | CERALOY |
Classification | Alloy, Metal, Base |
Applicant | NEIRYNCK & VOGT NV 12960 STONECREEK DR. Pickerington, OH 43147 |
Contact | Josh Andrachek |
Correspondent | Josh Andrachek NEIRYNCK & VOGT NV 12960 STONECREEK DR. Pickerington, OH 43147 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-17 |
Decision Date | 2002-08-01 |