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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K982865
Device Name ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT
Applicant
Atrix Laboratories, Inc.
2579 Midpoint Dr.
Fort Collins,  CO  80525 -4417
Applicant Contact ELYSE WOLFF
Correspondent
Atrix Laboratories, Inc.
2579 Midpoint Dr.
Fort Collins,  CO  80525 -4417
Correspondent Contact ELYSE WOLFF
Regulation Number872.3930
Classification Product Code
NPK  
Date Received08/13/1998
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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