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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cushion, Hemorrhoid
510(k) Number K932396
Device Name PERI-COMFORT(TM) SEATING CUSHION
Applicant
Chi'Am Intl.
P.O. Box 445
Circle Pines,  MN  55014
Applicant Contact SUSAN WOLF
Correspondent
Chi'Am Intl.
P.O. Box 445
Circle Pines,  MN  55014
Correspondent Contact SUSAN WOLF
Classification Product Code
LRL  
Date Received05/18/1993
Decision Date 09/30/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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