The following data is part of a premarket notification filed by Pilling Co. with the FDA for Pilling Brush Valvulotome.
Device ID | K904507 |
510k Number | K904507 |
Device Name: | PILLING BRUSH VALVULOTOME |
Classification | Stripper, Vein, External |
Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Sherry Krider |
Correspondent | Sherry Krider PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | DWQ |
CFR Regulation Number | 870.4885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-02 |
Decision Date | 1991-03-01 |