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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963491
Device Name STUCKEY STRAP-3 FINGER RESTRAINTS
Applicant
STUCKEY ENT., INC.
13629 CATAMARAN
CORPUS CHRISTI,  TX  78418
Applicant Contact JUDY STUCKEY
Correspondent
STUCKEY ENT., INC.
13629 CATAMARAN
CORPUS CHRISTI,  TX  78418
Correspondent Contact JUDY STUCKEY
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received09/03/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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