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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K894907
Device Name MARK IV HAND, THUMB AND WRIST (CPM) UNIT
Applicant
Innovative Medical Engineering, Inc.
13402 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact LEN KATZIN
Correspondent
Innovative Medical Engineering, Inc.
13402 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact LEN KATZIN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received08/01/1989
Decision Date 10/06/1989
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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