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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anchor, Fascial
510(k) Number K010277
Device Name AMS FASCIAL-ANCHORING SYSTEM
Applicant
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Applicant Contact ELSA LINKE
Correspondent
American Medical Systems, Inc.
10700 Bren Rd. W.
Minnetonka,  MN  55343
Correspondent Contact ELSA LINKE
Regulation Number878.4300
Classification Product Code
NEH  
Date Received01/30/2001
Decision Date 03/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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