FDA 510(k) Application Details - K982604

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K982604
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US Other 510(k) Applications for this Company
Contact	DIANA PRESTON Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	MQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/1998
Decision Date	10/23/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review