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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 K951847
Device Name AVANTGARDE
Applicant
Otto Bock Orthopedic Industry, Inc.
3000 Xenium Ln., Suite N
Plymouth,  MN  55441
Applicant Contact MARY KAY BUESCHER
Correspondent
Otto Bock Orthopedic Industry, Inc.
3000 Xenium Ln., Suite N
Plymouth,  MN  55441
Correspondent Contact MARY KAY BUESCHER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/20/1995
Decision Date 05/12/1995
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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