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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
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