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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850875
Device Name ACTION-WHEELS & PLAY WHEELS
Applicant
Ketronic, Inc.
Duinkerkenlaan 31
5627 Ma Eindhoven
The Netherlands,  NL
Applicant Contact VANDILL
Correspondent
Ketronic, Inc.
Duinkerkenlaan 31
5627 Ma Eindhoven
The Netherlands,  NL
Correspondent Contact VANDILL
Date Received03/01/1985
Decision Date 05/16/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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