The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Safety Needle.
| Device ID | K012736 |
| 510k Number | K012736 |
| Device Name: | MONOJECT SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05907527942194 | K012736 | 000 |
| 10884521155480 | K012736 | 000 |
| 10884521155466 | K012736 | 000 |
| 20884521145044 | K012736 | 000 |
| 30884521000661 | K012736 | 000 |
| 20884521000657 | K012736 | 000 |
| 20884521000602 | K012736 | 000 |
| 20884521000589 | K012736 | 000 |
| 20884521000572 | K012736 | 000 |
| 20884521000565 | K012736 | 000 |
| 30884521000555 | K012736 | 000 |
| 20884521000541 | K012736 | 000 |
| 20884521000534 | K012736 | 000 |
| 30884521000524 | K012736 | 000 |
| 30884521000517 | K012736 | 000 |
| 30884521000494 | K012736 | 000 |
| 30884521000487 | K012736 | 000 |
| 30884521000470 | K012736 | 000 |
| 10884521155497 | K012736 | 000 |
| 10884521155510 | K012736 | 000 |
| 10884521155527 | K012736 | 000 |
| 05907527942095 | K012736 | 000 |
| 05907527942088 | K012736 | 000 |
| 05907527942033 | K012736 | 000 |
| 05907527942026 | K012736 | 000 |
| 10884521163058 | K012736 | 000 |
| 10884521150485 | K012736 | 000 |
| 10884521143067 | K012736 | 000 |
| 10884521201934 | K012736 | 000 |
| 10884521201927 | K012736 | 000 |
| 20884521163048 | K012736 | 000 |
| 10884521155640 | K012736 | 000 |
| 10884521155633 | K012736 | 000 |
| 10884521155626 | K012736 | 000 |
| 10884521155619 | K012736 | 000 |
| 10884521155602 | K012736 | 000 |
| 10884521155541 | K012736 | 000 |
| 10884521155534 | K012736 | 000 |
| 20884521000084 | K012736 | 000 |