FDA 510(k) Application Details - K972551

Device Classification Name	Lavage, Jet   More FDA Info for this Device
510(K) Number	K972551
Device Name	Lavage, Jet
Applicant	HOWMEDICA CORP. 359 VETERANS BLVD. RUTHERFORD, NJ 07070 US Other 510(k) Applications for this Company
Contact	MARGARET F CROWE Other 510(k) Applications for this Contact
Regulation Number	880.5475   More FDA Info for this Regulation Number
Classification Product Code	FQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/1997
Decision Date	10/29/1997
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