The following data is part of a premarket notification filed by Stat Medical Devices, Inc. with the FDA for Super-fine Pen Needle.
| Device ID | K092016 |
| 510k Number | K092016 |
| Device Name: | SUPER-FINE PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | STAT MEDICAL DEVICES, INC. 2056 NE 153RD ST. North Miami Beach, FL 33162 |
| Contact | Mary L Jean |
| Correspondent | Mary L Jean STAT MEDICAL DEVICES, INC. 2056 NE 153RD ST. North Miami Beach, FL 33162 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-10-02 |
| Summary: | summary |