FDA 510(k) Application Details - K980109

Device Classification Name Dispenser, Liquid Medication

  More FDA Info for this Device
510(K) Number K980109
Device Name Dispenser, Liquid Medication
Applicant SANGSTAT MEDICAL CORP.
6300 DUMBARTON CIRCLE
FREMONT, CA 94555 US
Other 510(k) Applications for this Company
Contact DEREK WILLIAMS
Other 510(k) Applications for this Contact
Regulation Number 880.6430

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

  More FDA Info for this Product Code
Date Received 01/12/1998
Decision Date 08/18/1998
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