FDA 510(k) Application Details - K971692

Device Classification Name	Handpiece, Rotary Bone Cutting   More FDA Info for this Device
510(K) Number	K971692
Device Name	Handpiece, Rotary Bone Cutting
Applicant	OSTEOMED CORP. 3150 PREMIER DR. #110 IRVING, TX 75063 US Other 510(k) Applications for this Company
Contact	CINDY WALTERS Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	KMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/1997
Decision Date	06/27/1997
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