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 Tube, Gastro-Enterostomy
510(k) Number K980145
Device Name AMT DECOMPRESSION TUBES
Applicant
APPLIED MEDICAL TECHNOLOGY, INC.
15653 NEO PKWY.
CLEVELAND,  OH  44128
Applicant Contact THOMAS W PARKINSON
Correspondent
APPLIED MEDICAL TECHNOLOGY, INC.
15653 NEO PKWY.
CLEVELAND,  OH  44128
Correspondent Contact THOMAS W PARKINSON
Regulation Number876.5980
Classification Product Code
KGC  
Date Received01/15/1998
Decision Date 04/10/1998
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
-
-