The following data is part of a premarket notification filed by Julie Alliance with the FDA for Quickray Dsx 730.
Device ID | K990002 |
510k Number | K990002 |
Device Name: | QUICKRAY DSX 730 |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | JULIE ALLIANCE 1095 MASON AVE. Daytona Beach, FL 32117 |
Contact | Claude D Berhoin |
Correspondent | Claude D Berhoin JULIE ALLIANCE 1095 MASON AVE. Daytona Beach, FL 32117 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-04 |
Decision Date | 1999-04-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858475006085 | K990002 | 000 |
00858475006078 | K990002 | 000 |