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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, cast
510(k) Number K770340
Device Name BANDAGES, PLASTER OF PARIS & SPLINTS
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 Number890.3025
Classification Product Code
ITG  
Date Received02/18/1977
Decision Date 02/28/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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