FDA 510(k) Application Details - K964596

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K964596
Device Name	Scaler, Ultrasonic
Applicant	PROFESSIONAL DENTAL MFG., INC. P.O. BOX 4129 BATESVILLE, AR 72503 US Other 510(k) Applications for this Company
Contact	BOB ZAHRADNIK Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1996
Decision Date	04/22/1997
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