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510(k) K944481

THE HEART PROTECTOR by Garan Scientific, Inc. — Product Code NXB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 10, 1995
Date Received: September 13, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dispenser, Solid Medication
Device Class: Class I
Regulation Number: 890.5050
Review Panel: HO
Submission Type

A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.