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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K843581
Device Name PROM NAID
Applicant
Lossing Orthopedic, Inc.
2217 Nicollet Ave.
Minneapolis,  MN  55404
Applicant Contact SUSAN G WOLF
Correspondent
Lossing Orthopedic, Inc.
2217 Nicollet Ave.
Minneapolis,  MN  55404
Correspondent Contact SUSAN G WOLF
Regulation Number890.5900
Classification Product Code
ITH  
Date Received09/11/1984
Decision Date 12/11/1984
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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