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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Surgical With Orthopedic Accessories, Ac-Powered
510(k) Number K900290
Device Name SKYTRON MODEL 1100 AND MODEL 142
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 Number878.4960
Classification Product Code
JEA  
Date Received01/22/1990
Decision Date 02/20/1990
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
Predetermined Change
Control Plan Authorized		 No
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