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510(k) Premarket Notification

 

Device Classification Name

Stimulator, Cranial Electrotherapy

510(k) Number

K903014

Regulation Number

882.5800

Device Name

ALPHA-STIM CS

Applicant

ELECTROMEDICAL PRODUCTS, INC.

Contact

L Kirsch

Classification Product Code

JXK

Date Received

07/10/1990

Decision Date

05/12/1992

Classification Advisory Committee

Neurology

Review Advisory Committee

Neurology

Statement/Summary/Purged Status

Purged, no summary or statement

Type

Traditional

Reviewed by Third Party

No