The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Modified Novy Cornual Cannulation Set.
Device ID | K180552 |
510k Number | K180552 |
Device Name: | Modified Novy Cornual Cannulation Set |
Classification | Catheters, Salpingography |
Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
Contact | Naomi Funkhouser |
Correspondent | Naomi Funkhouser Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
Product Code | MOV |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-01 |
Decision Date | 2018-07-12 |
Summary: | summary |