The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Emerg. Oxygen Kit #65350 & #65399 Case.
| Device ID | K802644 |
| 510k Number | K802644 |
| Device Name: | EMERG. OXYGEN KIT #65350 & #65399 CASE |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | B & F MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-24 |
| Decision Date | 1980-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720012114 | K802644 | 000 |
| 00026072012116 | K802644 | 000 |