The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Myelography Tray W/cuatico Myelograp N.
Device ID | K760643 |
510k Number | K760643 |
Device Name: | MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N |
Classification | Injector, Contrast Medium, Automatic |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
Product Code | IZQ |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-14 |
Decision Date | 1976-10-08 |