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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name exerciser, measuring
510(k) Number K834360
Device Name 3-D PASSIVE MOBILIZER
Applicant
3-D ORTHOPEDIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
3-D ORTHOPEDIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number890.5360
Classification Product Code
ISD  
Date Received12/13/1983
Decision Date 01/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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