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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 K844995
Device Name SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE
Applicant
Cropper Medical, Inc.
3007 N. 73rd. St.
Suite D
Scottsdale,  AZ  85251
Correspondent
Cropper Medical, Inc.
3007 N. 73rd. St.
Suite D
Scottsdale,  AZ  85251
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/26/1984
Decision Date 04/01/1985
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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