FDA 510(k) Application Details - K954352

Device Classification Name	Block, Bite   More FDA Info for this Device
510(K) Number	K954352
Device Name	Block, Bite
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	GRETCHEN YOUNKER Other 510(k) Applications for this Contact
Regulation Number	882.5070   More FDA Info for this Regulation Number
Classification Product Code	JXL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/1995
Decision Date	01/25/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review