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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 K871313
Device Name ULTRA-FRESH DEODORANT
Applicant
Mentor Corp.
2700 Fwy. Blvd.
Minneapolis,  MN  55430
Applicant Contact DAVID J GAMBLE
Correspondent
Mentor Corp.
2700 Fwy. Blvd.
Minneapolis,  MN  55430
Correspondent Contact DAVID J GAMBLE
Regulation Number876.5900
Classification Product Code
GDS  
Date Received04/01/1987
Decision Date 03/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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