The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for 14x14 Multiformat Spot Filmer, No. 6650.400.
Device ID | K881589 |
510k Number | K881589 |
Device Name: | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 |
Classification | Device, Spot-film |
Applicant | CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago, IL 60680 |
Contact | James M Taylor |
Correspondent | James M Taylor CONTINENTAL X-RAY CORP. POST OFFICE BOX 5571 Chicago, IL 60680 |
Product Code | IXL |
CFR Regulation Number | 892.1670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-13 |
Decision Date | 1988-07-18 |