FDA 510(k) Application Details - K982638

Device Classification Name	More FDA Info for this Device
510(K) Number	K982638
Device Name	3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
Applicant	INNOVATIVE TECHNOLOGIES LTD. ROAD THREE, WINSFORD INDUSTRIAL ESTATE WINSFORD, CHESHIRE CW7 3PD GB Other 510(k) Applications for this Company
Contact	CHRIS OAKES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/1998
Decision Date	08/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review