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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Cine, Endoscopic, Without Audio
510(k) Number K951519
Device Name WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
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 Number878.4160
Classification Product Code
FWL  
Date Received04/03/1995
Decision Date 06/14/1995
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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