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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K882418
Device Name DRY COMFORT UNDERGARMENT
Applicant
HEALTH TEC, INC.
FIRST ST.
PALMER,  MA  01069
Applicant Contact ANTHONY HAY
Correspondent
HEALTH TEC, INC.
FIRST ST.
PALMER,  MA  01069
Correspondent Contact ANTHONY HAY
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received06/13/1988
Decision Date 09/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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