FDA 510(k) Application Details - K863915

Device Classification Name Heavy Metals Control Materials

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510(K) Number K863915
Device Name Heavy Metals Control Materials
Applicant SHAPE PRODUCTS CO.
1127 57TH AVE.
OAKLAND, CA US
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Contact DWIGHT GUSTAFSON
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Regulation Number 862.3280

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Classification Product Code DIE
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Date Received 10/08/1986
Decision Date 11/24/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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