The following data is part of a premarket notification filed by F. & F. Koenigkramer with the FDA for Reliance 1000, Reliance 1500, Reliance 2000.
| Device ID | K853149 | 
| 510k Number | K853149 | 
| Device Name: | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | 
| 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 |