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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K994137
Device Name ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
Applicant
Atrix Laboratories, Inc.
2579 Midpoint Dr.
Fort Collins,  CO  80525 -4417
Applicant Contact AMY TAYLOR
Correspondent
Atrix Laboratories, Inc.
2579 Midpoint Dr.
Fort Collins,  CO  80525 -4417
Correspondent Contact AMY TAYLOR
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/07/1999
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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