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 |