The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hypodermic Needle-pro Safety Allergy Tray.
Device ID | K072482 |
510k Number | K072482 |
Device Name: | HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY |
Classification | Syringe, Antistick |
Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
Contact | Brian Farias |
Correspondent | Brian Farias SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-04 |
Decision Date | 2007-11-29 |
Summary: | summary |