The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Bottle Adapter.
Device ID | K830571 |
510k Number | K830571 |
Device Name: | BOTTLE ADAPTER |
Classification | Dispenser, Liquid Medication |
Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KYX |
CFR Regulation Number | 880.6430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-23 |
Decision Date | 1983-03-24 |