The following data is part of a premarket notification filed by Exelint International Co. with the FDA for Exelint Securetouch Safety Hypodermic Needle.
| Device ID | K152183 |
| 510k Number | K152183 |
| Device Name: | EXELINT SecureTouch Safety Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | EXELINT INTERNATIONAL CO. 2500 Santa Fe Avenue Redondo Beach, CA 90278 |
| Contact | Navid Hamid |
| Correspondent | Navid Hamid EXELINT INTERNATIONAL CO. 2500 Santa Fe Avenue Redondo Beach, CA 90278 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2015-11-02 |
| Summary: | summary |