FDA 510(k) Application Details - K971381

Device Classification Name Surgeon'S Gloves

  More FDA Info for this Device
510(K) Number K971381
Device Name Surgeon'S Gloves
Applicant ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
Other 510(k) Applications for this Company
Contact MARYALICE SMITH
Other 510(k) Applications for this Contact
Regulation Number 878.4460

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

  More FDA Info for this Product Code
Date Received 04/14/1997
Decision Date 07/09/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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