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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 K941426
Device Name SYMBIOSIS REUSABLE MONOPOLAR ELECTROSURGICAL PROBE
Applicant
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Applicant Contact KEVIN SMITH
Correspondent
Symbiosis Corp.
8600 NW 41 St.
Miami,  FL  33166
Correspondent Contact KEVIN SMITH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/24/1994
Decision Date 06/22/1994
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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