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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Components, Wheelchair
510(k) Number K890178
Device Name WHEELCHAIR STUMP SUPPORT
Applicant
Gerber Chair Mates, Inc.
1171 Ringling Ave.
Johnstown,  PA  15902
Applicant Contact JAMES R GERBER
Correspondent
Gerber Chair Mates, Inc.
1171 Ringling Ave.
Johnstown,  PA  15902
Correspondent Contact JAMES R GERBER
Regulation Number890.3920
Classification Product Code
KNN  
Date Received01/17/1989
Decision Date 09/11/1989
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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