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FDA 510(k) Application Details - K972446
Device Classification Name
Restraint, Protective
More FDA Info for this Device
510(K) Number
K972446
Device Name
Restraint, Protective
Applicant
CAVITY FREE KIDS, INC.
1224 ARCADE ST.
ST. PAUL, MN 55106 US
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Contact
VACHAREE S PETERSON
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
06/30/1997
Decision Date
11/13/1997
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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