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FDA 510(k) Application Details - K963547
Device Classification Name
Restraint, Protective
More FDA Info for this Device
510(K) Number
K963547
Device Name
Restraint, Protective
Applicant
SAFE RESTRAINTS, INC.
1500 NEWELL AVE.
#408
WALNUT CREEK, CA 94596 US
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Contact
MARK RYCHLIK
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
09/05/1996
Decision Date
12/02/1996
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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