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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K875034
Device Name SWEDE CHAMP (WHEELCHAIR)
Applicant
Etac Us, Inc.
2233 W. Mill Rd.
Glendale,  WI  53209
Applicant Contact MELODY B DILL
Correspondent
Etac Us, Inc.
2233 W. Mill Rd.
Glendale,  WI  53209
Correspondent Contact MELODY B DILL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/07/1987
Decision Date 01/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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