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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name protector, skin pressure
510(k) Number K771519
Device Name SPECIALIST ARM & LEG PROTECTOR
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Regulation Number880.6450
Classification Product Code
FMP  
Date Received08/08/1977
Decision Date 08/26/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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