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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K830707
Device Name ACUFEX UNIVERSAL LEG HOLDER
Applicant
ACUFEX MICROSURGICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ACUFEX MICROSURGICAL, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received03/07/1983
Decision Date 05/02/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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