510(k) K892715

IFA SENSIBAC NITROFURANTOIN by Investigacion Farmaceutica S.A. DE C.V. — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1989
Date Received
April 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type