The following data is part of a premarket notification filed by Feel Tech with the FDA for Disposable Hypodermic Needle.
Device ID | K092831 |
510k Number | K092831 |
Device Name: | DISPOSABLE HYPODERMIC NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | FEEL TECH 300 ATWOOD Pittsburgh, PA 15213 |
Contact | Peter Chun |
Correspondent | Peter Chun FEEL TECH 300 ATWOOD Pittsburgh, PA 15213 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-15 |
Decision Date | 2010-01-14 |
Summary: | summary |