The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Irrigation Set.
| Device ID | K964067 |
| 510k Number | K964067 |
| Device Name: | GORE IRRIGATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. P.O. BOX 2200 Flagstaff, AZ 86003 -2200 |
| Contact | Dawn Lopez |
| Correspondent | Dawn Lopez W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. P.O. BOX 2200 Flagstaff, AZ 86003 -2200 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-10 |
| Decision Date | 1997-06-05 |
| Summary: | summary |