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FDA 510(k) Application Details - K963452
Device Classification Name
Restraint, Protective
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510(K) Number
K963452
Device Name
Restraint, Protective
Applicant
MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN, IL 60060 US
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Contact
LARA N SIMMONS
Other 510(k) Applications for this Contact
Regulation Number
880.6760
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Classification Product Code
FMQ
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More FDA Info for this Product Code
Date Received
09/03/1996
Decision Date
10/18/1996
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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