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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Traction, Non-Powered
510(k) Number K844239
Device Name NEC-KRADLE BY VENCOR
Applicant
VENCOR
50 CURTNER AVE., #9
CAMPBELL,  CA  95008
Applicant Contact JOAN K GRAHAM
Correspondent
VENCOR
50 CURTNER AVE., #9
CAMPBELL,  CA  95008
Correspondent Contact JOAN K GRAHAM
Regulation Number888.5850
Classification Product Code
HST  
Date Received11/01/1984
Decision Date 11/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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