FDA 510(k) Application Details - K971641

Device Classification Name	Gutta-Percha   More FDA Info for this Device
510(K) Number	K971641
Device Name	Gutta-Percha
Applicant	DR. HOWARD MARTIN, P.A. 4327 REELS MILL RD. FREDERICK, MD 21704 US Other 510(k) Applications for this Company
Contact	KYLE H SIBINOVIC Other 510(k) Applications for this Contact
Regulation Number	872.3850   More FDA Info for this Regulation Number
Classification Product Code	EKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/1997
Decision Date	07/21/1997
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