The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Burron Multi-ad Syringe Cap.
Device ID | K801311 |
510k Number | K801311 |
Device Name: | BURRON MULTI-AD SYRINGE CAP |
Classification | Syringe, Piston |
Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-03 |
Decision Date | 1980-06-17 |