510(k) K821597

BRAIN HEART INFUSION by Hardy Media — Product Code JSC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1982
Date Received
May 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type