510(k) K760313

KIT, PREP, INSPIRON IV by Inspiron Corp. — Product Code KZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusor, Pressure, For I.V. Bags
Device Class
Class I
Regulation Number
880.5420
Review Panel
HO
Submission Type