FDA 510(k) Application Details - K100628

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K100628
Device Name	Powered Light Based Non-Laser Surgical Instrument
Applicant	DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. BRYAN, OH 43506 US Other 510(k) Applications for this Company
Contact	MICHELE THIEL Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2010
Decision Date	11/24/2010
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