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 K933596
Device Name GASTRIC, CATHETER, IRRIGATION & ASPIRATION
Applicant
POLAMEDCO, INC.
8295 S.LA CIENEGA BLVD.
INGLEWOOD,  CA  90301 -1521
Applicant Contact JERRY W HARRER
Correspondent
POLAMEDCO, INC.
8295 S.LA CIENEGA BLVD.
INGLEWOOD,  CA  90301 -1521
Correspondent Contact JERRY W HARRER
Regulation Number876.5980
Classification Product Code
BSS  
Date Received07/26/1993
Decision Date 02/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-