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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Neurosurgical
510(k) Number K900472
Device Name SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Applicant Contact LARRY J PURCEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Correspondent Contact LARRY J PURCEY
Regulation Number882.4125
Classification Product Code
HBN  
Date Received01/31/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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