FDA 510(k) Application Details - K972646

Device Classification Name	Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K972646
Device Name	Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
Applicant	LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK CHICOPEE, MA 01022 US Other 510(k) Applications for this Company
Contact	PATRICK A MALIA Other 510(k) Applications for this Contact
Regulation Number	878.4022   More FDA Info for this Regulation Number
Classification Product Code	NAE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/1997
Decision Date	08/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review