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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heavy Metals Control Materials
510(k) Number K890721
Device Name SHAPE-ACTIO METAL TOXICOLOGY CONTROL
Applicant
Actio, Inc.
1127-57th Ave.
Oakland,  CA  94621
Applicant Contact LEWIN, PH.D.
Correspondent
Actio, Inc.
1127-57th Ave.
Oakland,  CA  94621
Correspondent Contact LEWIN, PH.D.
Regulation Number862.3280
Classification Product Code
DIE  
Date Received02/13/1989
Decision Date 04/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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