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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sling, Arm
510(k) Number K760250
Device Name BANDAGE, TRIANGULAR NO. 8068
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Regulation Number890.3640
Classification Product Code
ILI  
Date Received07/19/1976
Decision Date 07/26/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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