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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Rectal
510(k) Number K894618
Device Name INAMED RHEMO-D (TM) DILATOR
Applicant
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact ELLEN DUKE
Correspondent
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact ELLEN DUKE
Regulation Number876.5450
Classification Product Code
FFP  
Date Received07/20/1989
Decision Date 01/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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