The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Mic-key* Sf Over-the-wire Stoma Measuring Device.
| Device ID | K173955 |
| 510k Number | K173955 |
| Device Name: | Mic-Key* SF Over-the-Wire Stoma Measuring Device |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | David M Lee |
| Correspondent | David M Lee Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-28 |
| Decision Date | 2018-01-26 |
| Summary: | summary |