The following data is part of a premarket notification filed by J. Morita Mfg. Corp. with the FDA for Veraviewepocs Panoramic/cephalometric X-ray Unit With Cephalometric.
Device ID | K030699 |
510k Number | K030699 |
Device Name: | VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC |
Classification | Cephalometer |
Applicant | J. MORITA MFG. CORP. 1425 K ST. N.W. Washington, DC 20005 |
Contact | Keith A Barritt |
Correspondent | Keith A Barritt J. MORITA MFG. CORP. 1425 K ST. N.W. Washington, DC 20005 |
Product Code | EAG |
CFR Regulation Number | 872.1830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-06 |
Decision Date | 2003-05-29 |
Summary: | summary |