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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 K945805
Device Name WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE
Applicant
Wells Johnson Co.
8075 E Research Ct., Suite 101
P.O. Box 18230
Tucson,  AZ  85731
Applicant Contact BRENDA HUNT
Correspondent
Wells Johnson Co.
8075 E Research Ct., Suite 101
P.O. Box 18230
Tucson,  AZ  85731
Correspondent Contact BRENDA HUNT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/28/1994
Decision Date 12/13/1994
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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