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 K880201
Device Name REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
Applicant
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Applicant Contact PAUL BERNARD
Correspondent
SUPERIOR HEALTHCARE GROUP, INC.
CUMBERLAND INDUSTRIAL PARK
CUMBERLAND,  RI  02864
Correspondent Contact PAUL BERNARD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/15/1988
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-