The following data is part of a premarket notification filed by Koken Mfg Company, Inc. with the FDA for Model 6500 Opthalmic Chair.
| Device ID | K864494 |
| 510k Number | K864494 |
| Device Name: | MODEL 6500 OPTHALMIC CHAIR |
| Classification | Chair, Ophthalmic, 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 | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-14 |
| Decision Date | 1986-12-15 |