The following data is part of a premarket notification filed by Exelint International Co. with the FDA for Exelint Aluminum Hub Blunt Needles.
| Device ID | K101309 |
| 510k Number | K101309 |
| Device Name: | EXELINT ALUMINUM HUB BLUNT NEEDLES |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90045 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90045 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2010-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30020221264723 | K101309 | 000 |
| 10020221264576 | K101309 | 000 |
| 10020221264569 | K101309 | 000 |
| 10020221264552 | K101309 | 000 |
| 10020221264545 | K101309 | 000 |
| 10020221264521 | K101309 | 000 |
| 10020221264514 | K101309 | 000 |
| 10020221264507 | K101309 | 000 |
| 10020221564553 | K101309 | 000 |
| 10020221064633 | K101309 | 000 |
| 10020221264583 | K101309 | 000 |
| 10020221264613 | K101309 | 000 |
| 10020221264620 | K101309 | 000 |
| 30020221264716 | K101309 | 000 |
| 30020221264754 | K101309 | 000 |
| 30020221264747 | K101309 | 000 |
| 30020221264730 | K101309 | 000 |
| 10020221264682 | K101309 | 000 |
| 10020221264675 | K101309 | 000 |
| 10020221264668 | K101309 | 000 |
| 10020221264651 | K101309 | 000 |
| 10020221264644 | K101309 | 000 |
| 10020221064558 | K101309 | 000 |