FDA 510(k) Application Details - K914276

Device Classification Name Latex Patient Examination Glove

  More FDA Info for this Device
510(K) Number K914276
Device Name Latex Patient Examination Glove
Applicant SIME HEALTH, LTD.
1200 SIXTH AVE. SOUTH
SEATTLE, WA US
Other 510(k) Applications for this Company
Contact HELEN I MARIESKIND
Other 510(k) Applications for this Contact
Regulation Number 880.6250

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

  More FDA Info for this Product Code
Date Received 09/24/1991
Decision Date 12/04/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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