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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K981885
Device Name SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
Applicant
Sunrise Medical, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Applicant Contact REBECCA ANDERSEN
Correspondent
Sunrise Medical, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Correspondent Contact REBECCA ANDERSEN
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/29/1998
Decision Date 11/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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