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 Dilator, Esophageal
510(k) Number K990935
Device Name JACKSON ESOPHAGEAL DILATOR
Applicant
Pilling Weck Surgical
420 Delaware Dr.
Fort Washington,  PA  19034
Applicant Contact ELIZABETH LAZARO
Correspondent
Pilling Weck Surgical
420 Delaware Dr.
Fort Washington,  PA  19034
Correspondent Contact ELIZABETH LAZARO
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received03/19/1999
Decision Date 05/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-