The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Emodren Exchangeable Plastic Bellows.
| Device ID | K853295 |
| 510k Number | K853295 |
| Device Name: | EMODREN EXCHANGEABLE PLASTIC BELLOWS |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| 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 | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-06 |
| Decision Date | 1985-08-20 |