The following data is part of a premarket notification filed by Luther Needlesafe Products, Inc. with the FDA for Low Profile Luther Safety Huber.
| Device ID | K040527 |
| 510k Number | K040527 |
| Device Name: | LOW PROFILE LUTHER SAFETY HUBER |
| Classification | Set, Administration, Intravascular |
| Applicant | LUTHER NEEDLESAFE PRODUCTS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland LUTHER NEEDLESAFE PRODUCTS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-01 |
| Decision Date | 2004-03-26 |
| Summary: | summary |