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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K882802
Device Name STORZ DISPOSABLE BIPOLAR PENCILS
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact DAN REGAN
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact DAN REGAN
Regulation Number882.4725
Classification Product Code
GXI  
Date Received07/07/1988
Decision Date 08/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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