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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K871250
Device Name INTRA-ARTICULATED ARTHRO POWER SYSTEM
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact CHARLES P GILL
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact CHARLES P GILL
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/30/1987
Decision Date 04/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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