The following data is part of a premarket notification filed by Eureduc with the FDA for Eureduc Pneumatic Drainage System Model Tp03.
Device ID | K960902 |
510k Number | K960902 |
Device Name: | EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03 |
Classification | Sleeve, Limb, Compressible |
Applicant | EUREDUC 5, AVENUE RESIDENCE Antont, FR 92160 |
Contact | Philippe P Joubert |
Correspondent | Philippe P 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 | 1996-03-05 |
Decision Date | 1996-09-26 |
Summary: | summary |