The following data is part of a premarket notification filed by Freudenberg Medical Mis, Inc with the FDA for Flexseal Introducer Sheath With Hydrophilic Coating.
| Device ID | K190628 |
| 510k Number | K190628 |
| Device Name: | FlexSeal Introducer Sheath With Hydrophilic Coating |
| Classification | Introducer, Catheter |
| Applicant | Freudenberg Medical MIS, Inc 2301 Centennial Boulevard Jeffersonville, IN 47130 |
| Contact | Larry Bender |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-03-12 |
| Decision Date | 2019-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004312001 | K190628 | 000 |