The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Emodren Guide Needle For Drainage Tube & Emodren.
| Device ID | K853296 |
| 510k Number | K853296 |
| Device Name: | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN |
| Classification | Tube, Aspirating, Flexible, Connecting |
| Applicant | PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Contact | Julian P Kaye |
| Correspondent | Julian P Kaye PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Product Code | BYY |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-06 |
| Decision Date | 1985-08-15 |