FDA 510(k) Application Details - K980942

Device Classification Name Surgeon'S Gloves

  More FDA Info for this Device
510(K) Number K980942
Device Name Surgeon'S Gloves
Applicant LONDON INTERNATIONAL GROUP, INC.
2926 COLUMBIA HIGHWAY
P.O. BOX 8308
DOTHAM, AL 36303 US
Other 510(k) Applications for this Company
Contact NEIL ANDERSON
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 03/12/1998
Decision Date 05/11/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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