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 Tubes, Gastrointestinal (And Accessories)
510(k) Number K984628
Device Name MODIFICATION OF MOSS P.E.G. TRAY
Applicant
Moss Tubes, Inc.
304 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY SCHLAKMAN
Correspondent
Moss Tubes, Inc.
304 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY SCHLAKMAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/30/1998
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-