The following data is part of a premarket notification filed by Pilling Medical S.a. with the FDA for Disposable Yankauer Suction Tube.
Device ID | K904881 |
510k Number | K904881 |
Device Name: | DISPOSABLE YANKAUER SUCTION TUBE |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | PILLING MEDICAL S.A. LE FAGET Par Caraman, France 31460, FR |
Contact | Rika Steuperaert |
Correspondent | Rika Steuperaert PILLING MEDICAL S.A. LE FAGET Par Caraman, France 31460, FR |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-24 |
Decision Date | 1991-03-06 |