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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 K790320
Device Name DELTA-LITE
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Regulation Number890.3025
Classification Product Code
ITG  
Date Received02/15/1979
Decision Date 05/18/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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