The following data is part of a premarket notification filed by Exelint Intl. Co. with the FDA for Exel Comfortpoint Insulin Pen Needle.
| Device ID | K011757 |
| 510k Number | K011757 |
| Device Name: | EXEL COMFORTPOINT INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | EXELINT INTL. CO. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTL. CO. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-06 |
| Decision Date | 2002-01-23 |