The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Modification To: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe.
| Device ID | K032438 |
| 510k Number | K032438 |
| Device Name: | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE |
| Classification | Saline, Vascular Access Flush |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David Olson |
| Correspondent | David Olson TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-07 |
| Decision Date | 2004-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521005690 | K032438 | 000 |
| 10884521005761 | K032438 | 000 |
| 10884521005709 | K032438 | 000 |
| 10884521005631 | K032438 | 000 |
| 20884521005560 | K032438 | 000 |
| 20884521005553 | K032438 | 000 |
| 30884521005680 | K032438 | 000 |
| 30884521005666 | K032438 | 000 |