FDA 510(k) Application Details - K974062

Device Classification Name Sterilant, Medical Devices

  More FDA Info for this Device
510(K) Number K974062
Device Name Sterilant, Medical Devices
Applicant MEDSCI, INC.
P.O. BOX 5248
GREENSBORO, NC 27435 US
Other 510(k) Applications for this Company
Contact ROBERT MCINTOSH JR.
Other 510(k) Applications for this Contact
Regulation Number 880.6885

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

  More FDA Info for this Product Code
Date Received 10/27/1997
Decision Date 09/02/1998
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