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, Nasogastric
510(k) Number K891187
Device Name TECNOL NASO-GASTRIC TUBE HOLDER
Applicant
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Applicant Contact LEONA M HAMMEL
Correspondent
Tecnol New Jersey Wound Care, Inc.
7201 Industrial Park Blvd.
Fort Worth,  TX  76180
Correspondent Contact LEONA M HAMMEL
Regulation Number876.5980
Classification Product Code
BSS  
Date Received03/06/1989
Decision Date 05/30/1989
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
-
-