The following data is part of a premarket notification filed by Eureduc with the FDA for Eureduc Pneumatic Drainage System.
| Device ID | K954788 |
| 510k Number | K954788 |
| Device Name: | EUREDUC PNEUMATIC DRAINAGE SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | EUREDUC 5, AVENUE RESIDENCE Antont, FR 92160 |
| Contact | Philippe Joubert |
| Correspondent | Philippe Joubert EUREDUC 5, AVENUE RESIDENCE Antont, FR 92160 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1996-10-28 |
| Summary: | summary |