FDA 510(k) Application Details - K964445

Device Classification Name	Instruments, Surgical, Cardiovascular   More FDA Info for this Device
510(K) Number	K964445
Device Name	Instruments, Surgical, Cardiovascular
Applicant	DLP, INC. 620 WATSON S.W., P.O. BOX 409 GRAND RAPIDS, MI 49501 US Other 510(k) Applications for this Company
Contact	ROGER W BRICK Other 510(k) Applications for this Contact
Regulation Number	870.4500   More FDA Info for this Regulation Number
Classification Product Code	DWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/1996
Decision Date	01/30/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review