The following data is part of a premarket notification filed by Corpak Medsystems, Inc. A Division Of Haylard Health with the FDA for Corgrip Ng/ni Tube Retention System.
| Device ID | K162110 |
| 510k Number | K162110 |
| Device Name: | CORGRIP NG/NI Tube Retention System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CORPAK MedSystems, Inc. A Division Of Haylard Health 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski CORPAK MedSystems, Inc. A Division Of Haylard Health 1001 Asbury Dr Buffalo Grove, IL 60089 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2016-09-15 |
| Summary: | summary |