FDA 510(k) Application Details - K981387

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K981387
Device Name	Elastomer, Silicone, For Scar Management
Applicant	MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. TAUNTON, MA 02780 US Other 510(k) Applications for this Company
Contact	PAUL NARDELLA Other 510(k) Applications for this Contact
Regulation Number	878.4025   More FDA Info for this Regulation Number
Classification Product Code	MDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1998
Decision Date	06/10/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review