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FDA 510(k) Application Details - K963491
Device Classification Name
Restraint, Protective
More FDA Info for this Device
510(K) Number
K963491
Device Name
Restraint, Protective
Applicant
STUCKEY ENT., INC.
13629 CATAMARAN
CORPUS CHRISTI, TX 78418 US
Other 510(k) Applications for this Company
Contact
JUDY STUCKEY
Other 510(k) Applications for this Contact
Regulation Number
880.6760
More FDA Info for this Regulation Number
Classification Product Code
FMQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/1996
Decision Date
11/14/1996
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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