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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 K803212
Device Name BAUER & BLACK ARM SLING W/DETACH. POUCH
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington,  DC  20006
Regulation Number890.3640
Classification Product Code
ILI  
Date Received12/17/1980
Decision Date 01/08/1981
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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