FDA 510(k) Application Details - K963527

Device Classification Name Restraint, Protective

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510(K) Number K963527
Device Name Restraint, Protective
Applicant ALIMED, INC.
1200 EAST ST.
DEDHAM, MA 02026 US
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Contact DONALD A LINCOLN
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Regulation Number 880.6760

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Classification Product Code FMQ
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Date Received 09/04/1996
Decision Date 10/31/1996
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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