The following data is part of a premarket notification filed by Gary Giancarlo with the FDA for Logo-nu-way.
Device ID | K800186 |
510k Number | K800186 |
Device Name: | LOGO-NU-WAY |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | GARY GIANCARLO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-29 |
Decision Date | 1980-02-26 |