FDA 510(k) Application Details - K101218

Device Classification Name	More FDA Info for this Device
510(K) Number	K101218
Device Name	PATCHASSIST
Applicant	POLYTOUCH MEDICAL LTD 755 WESTMINSTER STREET UNIT 120 PROVIDENCE, RI 02903 US Other 510(k) Applications for this Company
Contact	LEO BASTA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2010
Decision Date	06/17/2010
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