The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Catheters, Silicone Coated.
Device ID | K770256 |
510k Number | K770256 |
Device Name: | CATHETERS, SILICONE COATED |
Classification | Catheter, Urological |
Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-10 |
Decision Date | 1977-02-17 |