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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, operating-room, electrical
510(k) Number K940616
Device Name SKYTRON ELITE 3500 TABLE
Applicant
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST S.E.
P.O.BOX 888615
GRAND RAPIDS,  MI  49588 -8615
Applicant Contact DAVID M MEHNEY
Correspondent
SKYTRON, DIV. THE KMW GROUP, INC.
5000 36TH ST S.E.
P.O.BOX 888615
GRAND RAPIDS,  MI  49588 -8615
Correspondent Contact DAVID M MEHNEY
Regulation Number878.4960
Classification Product Code
GDC  
Date Received02/14/1994
Decision Date 06/13/1994
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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