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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bath, Sitz, Nonpowered
510(k) Number K862600
Device Name SITZ BATH
Applicant
W. C. Green, D.D.S.
103 Woodrow Wilson Dr.
Valdosta,  GA  31601
Correspondent
W. C. Green, D.D.S.
103 Woodrow Wilson Dr.
Valdosta,  GA  31601
Regulation Number890.5125
Classification Product Code
KTC  
Date Received07/08/1986
Decision Date 07/18/1986
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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