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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Lumbo-Sacral
510(k) Number K792269
Device Name WRIGHT DOW CORNING SOFTGOODS W/DOW
Applicant
Dow Corning Wright
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dow Corning Wright
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3490
Classification Product Code
IPY  
Date Received11/09/1979
Decision Date 02/05/1980
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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