FDA 510(k) Application Details - K963462

Device Classification Name Restraint, Protective

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510(K) Number K963462
Device Name Restraint, Protective
Applicant BIRD & CRONIN, INC.
1200 TRAPP RD.
SAINT PAUL, MN 55121 US
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Contact MICHAEL FRAZER
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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 11/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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