The following data is part of a premarket notification filed by F. & F. Koenigkramer with the FDA for Reliance 5000.
| Device ID | K853151 |
| 510k Number | K853151 |
| Device Name: | RELIANCE 5000 |
| Classification | Chair, Ophthalmic, Ac-powered |
| Applicant | F. & F. KOENIGKRAMER 96 CALDWELL DR. Cincinnati, OH 45216 |
| Contact | Semmelman |
| Correspondent | Semmelman F. & F. KOENIGKRAMER 96 CALDWELL DR. Cincinnati, OH 45216 |
| Product Code | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-29 |
| Decision Date | 1985-09-05 |