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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Non-Invasive
510(k) Number K871900
Device Name OVER DRAPE LEG HOLDER
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 Number888.5890
Classification Product Code
KQZ  
Date Received05/15/1987
Decision Date 06/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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