The following data is part of a premarket notification filed by Koken Mfg Company, Inc. with the FDA for Dr.500o Operating Table.
| Device ID | K864295 |
| 510k Number | K864295 |
| Device Name: | DR.500O OPERATING TABLE |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | KOKEN MFG COMPANY, INC. P.O. BOX 265 St. Louis, MO 63166 |
| Contact | Masaya Kosaka |
| Correspondent | Masaya Kosaka KOKEN MFG COMPANY, INC. P.O. BOX 265 St. Louis, MO 63166 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1986-11-19 |