FDA 510(k) Application Details - K982439

Device Classification Name	System, Skin Closure   More FDA Info for this Device
510(K) Number	K982439
Device Name	System, Skin Closure
Applicant	PROGRESSIVE SURGICAL PRODUCTS, INC. 89 GARDEN ST. WESTBURY, NY 11590 US Other 510(k) Applications for this Company
Contact	ROBERT ODDSEN Other 510(k) Applications for this Contact
Regulation Number	878.4320   More FDA Info for this Regulation Number
Classification Product Code	MKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/1998
Decision Date	09/08/1998
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