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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 K844385
Device Name ESCOTEK EST TRAC 401
Applicant
Nor-Am Patient Care Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact PAUL A JONES
Correspondent
Nor-Am Patient Care Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact PAUL A JONES
Regulation Number890.5900
Classification Product Code
ITH  
Date Received11/13/1984
Decision Date 05/01/1985
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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