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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K855005
Device Name FIBER MESH
Applicant
Fiber Mesh, Inc.
1465 Post Rd. E.
Westport,  CT  06880
Applicant Contact KENNETH J BERK
Correspondent
Fiber Mesh, Inc.
1465 Post Rd. E.
Westport,  CT  06880
Correspondent Contact KENNETH J BERK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/13/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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