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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 K883275
Device Name SWEDE ELITE, MECHANICAL WHEELCHAIR
Applicant
Etac Us, Inc.
2233 W. Mill Rd.
Glendale,  WI  53209
Applicant Contact CYNDI ELSNER
Correspondent
Etac Us, Inc.
2233 W. Mill Rd.
Glendale,  WI  53209
Correspondent Contact CYNDI ELSNER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/03/1988
Decision Date 08/18/1988
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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