FDA 510(k) Application Details - K974768

Device Classification Name	Lubricant, Patient   More FDA Info for this Device
510(K) Number	K974768
Device Name	Lubricant, Patient
Applicant	NICE-PAK PRODUCTS, INC. TWO NICE-PAK PARK ORANGEBURG, NY 10962-1376 US Other 510(k) Applications for this Company
Contact	GARY VANCE Other 510(k) Applications for this Contact
Regulation Number	880.6375   More FDA Info for this Regulation Number
Classification Product Code	KMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1997
Decision Date	01/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review