The following data is part of a premarket notification filed by Kosin Technologies, Llc with the FDA for Piggyback Irrigating System.
Device ID | K040094 |
510k Number | K040094 |
Device Name: | PIGGYBACK IRRIGATING SYSTEM |
Classification | System, Irrigation, Urological |
Applicant | KOSIN TECHNOLOGIES, LLC 3305 GREYFOX DRIVE Valparaiso, IN 46383 |
Contact | Avtar S Dhindsa |
Correspondent | Avtar S Dhindsa KOSIN TECHNOLOGIES, LLC 3305 GREYFOX DRIVE Valparaiso, IN 46383 |
Product Code | LJH |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-01-16 |
Decision Date | 2004-04-15 |
Summary: | summary |