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, feeding
510(k) Number K897181
Device Name L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
Applicant
INTL. MEDICAL MARKETING, INC.
P.O. BOX 578
RIDGE,  NY  11961
Applicant Contact RAMON MONAST
Correspondent
INTL. MEDICAL MARKETING, INC.
P.O. BOX 578
RIDGE,  NY  11961
Correspondent Contact RAMON MONAST
Regulation Number876.5980
Classification Product Code
FPD  
Date Received12/28/1989
Decision Date 03/27/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-