The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Dryseal Sheath.
| Device ID | K093791 |
| 510k Number | K093791 |
| Device Name: | GORE DRYSEAL SHEATH |
| Classification | Introducer, Catheter |
| Applicant | W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LANE Flagstaff, AZ 86001 -0500 |
| Contact | Alicia Hemphill |
| Correspondent | Alicia Hemphill W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LANE Flagstaff, AZ 86001 -0500 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-03-22 |
| Summary: | summary |