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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 K020304
Device Name DISPOSABLE LIGHT HANDLE AND ADAPTOR
Applicant
Aspen Surgical Products, Inc.
7425 Clyde Park, Suite G
Grand Rapids,  MI  49315 -0404
Applicant Contact ROY MELLING
Correspondent
Aspen Surgical Products, Inc.
7425 Clyde Park, Suite G
Grand Rapids,  MI  49315 -0404
Correspondent Contact ROY MELLING
Regulation Number878.4580
Classification Product Code
FTA  
Date Received01/29/2002
Decision Date 02/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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