FDA 510(k) Application Details - K973200

Device Classification Name	Device, Caries Detection   More FDA Info for this Device
510(K) Number	K973200
Device Name	Device, Caries Detection
Applicant	PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	NELSON J GENDUSA Other 510(k) Applications for this Contact
Regulation Number	872.1740   More FDA Info for this Regulation Number
Classification Product Code	LFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/1997
Decision Date	11/06/1997
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