FDA 510(k) Application Details - K963466

Device Classification Name Restraint, Protective

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510(K) Number K963466
Device Name Restraint, Protective
Applicant DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL, TN 37849 US
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Contact CAMILLE MATLOCK
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Regulation Number 880.6760

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Classification Product Code FMQ
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Date Received 09/03/1996
Decision Date 02/13/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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