FDA 510(k) Application Details - K002718

Device Classification Name Latex Patient Examination Glove

  More FDA Info for this Device
510(K) Number K002718
Device Name Latex Patient Examination Glove
Applicant TILLOTSON HEALTHCARE CORP.
360 ROUTE 101
BEDFORD, NH 03110-5030 US
Other 510(k) Applications for this Company
Contact F.W. PERRELLA
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 08/31/2000
Decision Date 05/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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