The following data is part of a premarket notification filed by International Medical Device Partners, Inc. with the FDA for Guarded Needle 2000.
| Device ID | K003406 |
| 510k Number | K003406 |
| Device Name: | GUARDED NEEDLE 2000 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | INTERNATIONAL MEDICAL DEVICE PARTNERS, INC. 6801 IRIS CIRCLE Los Angeles, CA 90068 -2715 |
| Contact | James R Greenwood |
| Correspondent | James R Greenwood INTERNATIONAL MEDICAL DEVICE PARTNERS, INC. 6801 IRIS CIRCLE Los Angeles, CA 90068 -2715 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-01 |
| Decision Date | 2001-01-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GUARDED NEEDLE 2000 78003551 not registered Dead/Abandoned |
IMDP 2000-04-11 |