FDA 510(k) Application Details - K061690

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K061690
Device Name	Light, Surgical, Fiberoptic
Applicant	GULF MEDICAL FIBEROPTICS 148 DUNBAR AVE., UNIT B OLDSMAR, FL 34677 US Other 510(k) Applications for this Company
Contact	MARCELINO AFANADOR Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2006
Decision Date	09/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review