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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 K890085
Device Name SIT-N-BATHE SITZ BATH
Applicant
Drummond Industries, Inc.
1453 Etna Ave.
Huntington,  IN  46750
Applicant Contact E DRUMMOND
Correspondent
Drummond Industries, Inc.
1453 Etna Ave.
Huntington,  IN  46750
Correspondent Contact E DRUMMOND
Regulation Number890.5125
Classification Product Code
KTC  
Date Received01/10/1989
Decision Date 02/13/1989
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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