FDA 510(k) Application Details - K953865

Device Classification Name	Handpiece, Belt And/Or Gear Driven, Dental   More FDA Info for this Device
510(K) Number	K953865
Device Name	Handpiece, Belt And/Or Gear Driven, Dental
Applicant	J. MORITA USA, INC. 9 MASON IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	TERRY G MAHN Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/1995
Decision Date	03/20/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review