FDA 510(k) Application Details - K981869

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K981869
Device Name	Handpiece, Air-Powered, Dental
Applicant	PROFESSIONAL DENTAL MFG., INC. 633 LAWRENCE ST. BATESVILLE, AR 72501 US Other 510(k) Applications for this Company
Contact	BOB ZAHRADNIK Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/1998
Decision Date	08/11/1998
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