FDA 510(k) Application Details - K962290

Device Classification Name	Pad, Neonatal Eye   More FDA Info for this Device
510(K) Number	K962290
Device Name	Pad, Neonatal Eye
Applicant	DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	CAMILLE MATLOCK Other 510(k) Applications for this Contact
Regulation Number	880.5270   More FDA Info for this Regulation Number
Classification Product Code	FOK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/1996
Decision Date	07/03/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review