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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K894397
Device Name WELCON LIGHT HANDLE
Applicant
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Applicant Contact RICHARD P WELCH
Correspondent
Welcon, Inc.
99 Hartford Ave.
Providence,  RI  02909
Correspondent Contact RICHARD P WELCH
Regulation Number878.4580
Classification Product Code
FTA  
Date Received07/20/1989
Decision Date 08/10/1989
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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