The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Gripper Micro Needle.
| Device ID | K072059 |
| 510k Number | K072059 |
| Device Name: | GRIPPER MICRO NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Contact | Brian L Haugstad |
| Correspondent | Brian L Haugstad SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-26 |
| Decision Date | 2007-11-01 |
| Summary: | summary |