The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Farrell Valve With Corflo Anti-iv Connectors Model 20-4300aiv.
Device ID | K100365 |
510k Number | K100365 |
Device Name: | FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
Contact | Stephanie Wasielewski |
Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-02-12 |
Decision Date | 2010-05-20 |
Summary: | summary |