FDA 510(k) Application Details - K052858

Device Classification Name	Nursing Pad, Cohesive Gel   More FDA Info for this Device
510(K) Number	K052858
Device Name	Nursing Pad, Cohesive Gel
Applicant	PURONXY, INC. 9853 PACIFIC HEIGHTS BLVD. SUITE L SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	LESLIE SEBASTAIN Other 510(k) Applications for this Contact
Regulation Number	880.5630   More FDA Info for this Regulation Number
Classification Product Code	NXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2005
Decision Date	02/09/2006
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