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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K980483
Device Name MENTOR SUSPEND SLING
Original Applicant
MENTOR CORP.
5425 hollister ave.
santa barbara,  CA  93111
Original Contact donna a crawford
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/09/1998
Decision Date 04/30/1998
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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