The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Modification To Computed Oral Radiology System.
Device ID | K041385 |
510k Number | K041385 |
Device Name: | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
Classification | Unit, X-ray, Intraoral |
Applicant | SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE. Long Island City, NY 11101 |
Contact | Daniel Michaeli |
Correspondent | Daniel Michaeli SCHICK TECHNOLOGIES, INC. 30-00 47TH AVE. Long Island City, NY 11101 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-25 |
Decision Date | 2004-06-07 |
Summary: | summary |