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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Stomal
510(k) Number K883023
Device Name MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
Applicant
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Applicant Contact LYNN BRECKENRIDGE
Correspondent
MENTOR CORP.
600 PINE AVE.
GOLETA,  CA  93117
Correspondent Contact LYNN BRECKENRIDGE
Regulation Number876.5900
Classification Product Code
GDS  
Date Received07/19/1988
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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