The following data is part of a premarket notification filed by Charter Medical, Ltd. with the FDA for Charter Medical Neonatal Syringe Set.
| Device ID | K000685 |
| 510k Number | K000685 |
| Device Name: | CHARTER MEDICAL NEONATAL SYRINGE SET |
| Classification | Set, Blood Transfusion |
| Applicant | CHARTER MEDICAL, LTD. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Contact | K. Alice Preville |
| Correspondent | K. Alice Preville CHARTER MEDICAL, LTD. 1805 SWARTHMORE AVE. Lakewood, NJ 08701 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817827022715 | K000685 | 000 |
| 00817827022593 | K000685 | 000 |
| 00817827022586 | K000685 | 000 |
| 00817827022579 | K000685 | 000 |
| 00817827022562 | K000685 | 000 |
| 00817827022555 | K000685 | 000 |
| 00817827022548 | K000685 | 000 |
| 00817827022531 | K000685 | 000 |
| 00817827022524 | K000685 | 000 |
| 00817827022609 | K000685 | 000 |
| 00817827022616 | K000685 | 000 |
| 00817827022708 | K000685 | 000 |
| 00817827022692 | K000685 | 000 |
| 00817827022685 | K000685 | 000 |
| 00817827022678 | K000685 | 000 |
| 00817827022654 | K000685 | 000 |
| 00817827022647 | K000685 | 000 |
| 00817827022630 | K000685 | 000 |
| 00817827022623 | K000685 | 000 |
| 00817827022517 | K000685 | 000 |