The following data is part of a premarket notification filed by F. & F. Koenigkramer with the FDA for Reliance 6100.
Device ID | K853150 |
510k Number | K853150 |
Device Name: | RELIANCE 6100 |
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 |