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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 K942310
Device Name DYNASTY GC 12550 (GELL/CELL)
Applicant
Foley & Lardner
3000 K St. NW
Suite 500
Washington,  DC  20007
Applicant Contact ILENE K GOTTS
Correspondent
Foley & Lardner
3000 K St. NW
Suite 500
Washington,  DC  20007
Correspondent Contact ILENE K GOTTS
Regulation Number890.3920
Classification Product Code
KNN  
Date Received05/13/1994
Decision Date 11/07/1994
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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