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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Noninflatable, External, Sterile
510(k) Number K802522
Device Name DELTA-LITE CASTING TAPE & SPLINTS
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Regulation Number878.3910
Classification Product Code
FYH  
Date Received10/15/1980
Decision Date 01/08/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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