The following data is part of a premarket notification filed by X-ray Accessory Corp. with the FDA for Mitaya Aluminum Interspaced X-ray Grid.
Device ID | K964025 |
510k Number | K964025 |
Device Name: | MITAYA ALUMINUM INTERSPACED X-RAY GRID |
Classification | Grid, Radiographic |
Applicant | X-RAY ACCESSORY CORP. 207 DAY ST. Danielson, CT 06239 -2313 |
Contact | William Hague |
Correspondent | William Hague X-RAY ACCESSORY CORP. 207 DAY ST. Danielson, CT 06239 -2313 |
Product Code | IXJ |
CFR Regulation Number | 892.1910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-07 |
Decision Date | 1997-06-13 |