The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Latex Free Bionector.
Device ID | K052881 |
510k Number | K052881 |
Device Name: | VYGON LATEX FREE BIONECTOR |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
Contact | Courtney Smith |
Correspondent | Courtney Smith VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-12 |
Decision Date | 2006-03-02 |
Summary: | summary |