The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Treatment Table, Model #825-100.
Device ID | K930262 |
510k Number | K930262 |
Device Name: | TREATMENT TABLE, MODEL #825-100 |
Classification | Chair, Positioning, Electric |
Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1993-03-29 |