FDA 510(k) Application Details - K760777

Device Classification Name Kit, Enema, (For Cleaning Purpose)

  More FDA Info for this Device
510(K) Number K760777
Device Name Kit, Enema, (For Cleaning Purpose)
Applicant CARLTON HYGIENICS, INC.


Other 510(k) Applications for this Company
Regulation Number 876.5210

  More FDA Info for this Regulation Number
Classification Product Code FCE
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/04/1976
Decision Date 01/13/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact