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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formulations, Paraffin, All
510(k) Number K862223
Device Name MICRO THIN* PARAFFIN
Applicant
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Richard-Allan Medical Ind., Inc.
8850m89, Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number864.4010
Classification Product Code
KEO  
Date Received06/11/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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