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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 K863915
Device Name SHAPE-ACTIO METAL TOXICOLOGY CONTROL
Applicant
Shape Products Co.
1127 57th Ave.
Oakland,  CA  94621
Applicant Contact DWIGHT GUSTAFSON
Correspondent
Shape Products Co.
1127 57th Ave.
Oakland,  CA  94621
Correspondent Contact DWIGHT GUSTAFSON
Regulation Number862.3280
Classification Product Code
DIE  
Date Received10/08/1986
Decision Date 11/24/1986
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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