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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K933814
Device Name PHOTOSTRESS RECOVERY TESTER
Applicant
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact MICHAEL H SOUTHWORTH
Correspondent
Storz Instrument Co.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact MICHAEL H SOUTHWORTH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/04/1993
Decision Date 12/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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