The following data is part of a premarket notification filed by Browne Corp. with the FDA for Browne Model Ua-6.
Device ID | K792094 |
510k Number | K792094 |
Device Name: | BROWNE MODEL UA-6 |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | BROWNE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FAP |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-17 |
Decision Date | 1979-12-06 |