• 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 Enema Kit
510(k) Number K900847
Device Name ENEMA KIT 'Y' DESIGN
Applicant
CUSTOM MEDICAL PRODUCTS, LTD.
4101 SPRING MILL WAY
MAINEVILLE,  OH  45039
Applicant Contact GEORGE C SCHULER
Correspondent
CUSTOM MEDICAL PRODUCTS, LTD.
4101 SPRING MILL WAY
MAINEVILLE,  OH  45039
Correspondent Contact GEORGE C SCHULER
Regulation Number876.5210
Classification Product Code
FCE  
Date Received02/22/1990
Decision Date 04/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-