The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Ceph, Model 4900.
Device ID | K053558 |
510k Number | K053558 |
Device Name: | CEPH, MODEL 4900 |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE., FIFTH FLOOR Long Island City, NY 11101 |
Contact | Daniel Michaeli |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-12-21 |
Decision Date | 2006-02-17 |
Summary: | summary |