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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 K955838
Device Name ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)
Applicant
ATRIX LABORATORIES, INC.
2579 MIDPOINT DR.
FORT COLLINS,  CO  80525 -4417
Applicant Contact ELAINE M GAZDECK, R.A.C.
Correspondent
ATRIX LABORATORIES, INC.
2579 MIDPOINT DR.
FORT COLLINS,  CO  80525 -4417
Correspondent Contact ELAINE M GAZDECK, R.A.C.
Regulation Number872.3930
Classification Product Code
NPK  
Date Received12/22/1995
Decision Date 03/21/1996
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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