• 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 endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K962024
Device Name S-57 VIDEO IMAGING SYSTEM
Applicant
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Applicant Contact KARL J WEYDIG
Correspondent
DEL MEDICAL SYSTEMS CORP.
ONE COMMERCE PARK
VALHALLA,  NY  10595
Correspondent Contact KARL J WEYDIG
Regulation Number876.1500
Classification Product Code
FET  
Date Received05/23/1996
Decision Date 07/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-