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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Component, External, Limb, Ankle/Foot
510(k) Number K791331
Device Name THE TUCKER-SACH FOOT AND TUCKER-SYME FT
Applicant
Kiswood Manufacturing, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Kiswood Manufacturing, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3420
Classification Product Code
ISH  
Date Received07/18/1979
Decision Date 08/03/1979
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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