The following data is part of a premarket notification filed by Bd Medical Systems with the FDA for Bd Eclipse Hypodermic Needle.
| Device ID | K010188 |
| 510k Number | K010188 |
| Device Name: | BD ECLIPSE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD MEDICAL SYSTEMS 1 BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Contact | Greg W Morgan |
| Correspondent | Greg W Morgan BD MEDICAL SYSTEMS 1 BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903057899 | K010188 | 000 |
| 50382903057684 | K010188 | 000 |
| 50382903057677 | K010188 | 000 |
| 50382903057660 | K010188 | 000 |
| 50382903057653 | K010188 | 000 |
| 50382903057646 | K010188 | 000 |
| 50382903057639 | K010188 | 000 |
| 50382903057622 | K010188 | 000 |
| 50382903057615 | K010188 | 000 |
| 50382903057592 | K010188 | 000 |
| 50382903057585 | K010188 | 000 |
| 50382903057691 | K010188 | 000 |
| 50382903057783 | K010188 | 000 |
| 50382903057882 | K010188 | 000 |
| 50382903057875 | K010188 | 000 |
| 50382903057868 | K010188 | 000 |
| 50382903057851 | K010188 | 000 |
| 50382903057844 | K010188 | 000 |
| 50382903057837 | K010188 | 000 |
| 50382903057820 | K010188 | 000 |
| 50382903057813 | K010188 | 000 |
| 50382903057806 | K010188 | 000 |
| 50382903057790 | K010188 | 000 |
| 50382903057578 | K010188 | 000 |