The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Model 1750 Standing Urinal.
Device ID | K790663 |
510k Number | K790663 |
Device Name: | MODEL 1750 STANDING URINAL |
Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FFG |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-06 |
Decision Date | 1979-04-24 |