The following data is part of a premarket notification filed by Medical Radiation Devices, Inc. with the FDA for After Loading Device Kit.
Device ID | K893703 |
510k Number | K893703 |
Device Name: | AFTER LOADING DEVICE KIT |
Classification | System, Applicator, Radionuclide, Manual |
Applicant | MEDICAL RADIATION DEVICES, INC. P.O. BOX 6762 Dothan, AL 36302 |
Contact | William Kan |
Correspondent | William Kan MEDICAL RADIATION DEVICES, INC. P.O. BOX 6762 Dothan, AL 36302 |
Product Code | IWJ |
CFR Regulation Number | 892.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-18 |
Decision Date | 1989-09-18 |