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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K895800
Device Name ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR
Applicant
Advanced Surgical Products, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact JAMES C EASLEY
Correspondent
Advanced Surgical Products, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact JAMES C EASLEY
Regulation Number886.4100
Classification Product Code
HQR  
Date Received09/28/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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