The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Cannula Nasal Oxygen.
Device ID | K920573 |
510k Number | K920573 |
Device Name: | CANNULA NASAL OXYGEN |
Classification | Cannula, Nasal, Oxygen |
Applicant | B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
Contact | Jim Spillis |
Correspondent | Jim Spillis B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
Product Code | CAT |
CFR Regulation Number | 868.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-07 |
Decision Date | 1992-08-11 |