Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light Source, Endoscope, Xenon Arc
510(k) Number K924897
Device Name XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300
Applicant
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number876.1500
Classification Product Code
GCT  
Date Received09/29/1992
Decision Date 07/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-