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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 K871981
Device Name BILATERAL CONTINUOUS PASSIVE MOTION DEVICE
Applicant
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Applicant Contact AARON HEINTZ
Correspondent
Avec Scientific Design Corp.
605 S. 19th St.
Philadelphia,  PA  19146
Correspondent Contact AARON HEINTZ
Regulation Number890.5380
Classification Product Code
BXB  
Date Received05/22/1987
Decision Date 06/17/1987
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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