FDA 510(k) Applications Submitted by Eugene Chen

FDA 510(k) Number Submission Date Device Name Applicant
K180141 01/18/2018 SPIWay Endonasal Access Guide SPIWay, LLC
K213153 09/28/2021 SPIWay Endonasal Access Guide SPIWay, LLC
K153686 12/23/2015 SPIWay Endonasal Access Guide SPIWAY LLC
K980630 02/18/1998 FRIALIT-2 CORABASE FRIATEC AG
K982576 07/24/1998 FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476 FRIATEC AG
K991317 04/19/1999 POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM SAFESKIN CORP.
K991951 06/10/1999 SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) SAFESKIN CORP.
K992062 06/18/1999 SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES SAFESKIN CORP.
K992162 06/25/1999 SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM SAFESKIN CORP.
K992210 07/01/1999 SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES SAFESKIN CORP.
K992830 08/23/1999 SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE SAFESKIN CORP.
K993117 09/20/1999 SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG SAFESKIN CORP.
K994081 12/03/1999 SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES SAFESKIN CORP.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact