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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K911274
Device Name UNIPOLAR COAGULATOR PROBE SYSTEM
Applicant
American Surgical Instruments Corp.
901 E. Sample Rd., Suite C
Pompano Beach,  FL  33064
Applicant Contact DORSEY III
Correspondent
American Surgical Instruments Corp.
901 E. Sample Rd., Suite C
Pompano Beach,  FL  33064
Correspondent Contact DORSEY III
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/22/1991
Decision Date 06/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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