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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 K884347
Device Name MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
Applicant
Advanced Surgical Products, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact TODD J HESSEL
Correspondent
Advanced Surgical Products, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact TODD J HESSEL
Regulation Number882.4725
Classification Product Code
GXI  
Date Received10/14/1988
Decision Date 12/27/1988
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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