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 K920894
Device Name DECOMPRESSION TUBES
Applicant
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Applicant Contact PAT GILPIN
Correspondent
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Correspondent Contact PAT GILPIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/21/1992
Decision Date 04/28/1992
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
-
-