FDA 510(k) Application Details - K982865

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K982865
Device Name	Barrier, Synthetic, Intraoral
Applicant	ATRIX LABORATORIES, INC. 2579 MIDPOINT DR. FORT COLLINS, CO 80525-4417 US Other 510(k) Applications for this Company
Contact	ELYSE WOLFF Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/1998
Decision Date	09/08/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review