FDA 510(k) Application Details - K980392

Device Classification Name	Pump, Portable, Aspiration (Manual Or Powered)   More FDA Info for this Device
510(K) Number	K980392
Device Name	Pump, Portable, Aspiration (Manual Or Powered)
Applicant	BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 TUCSON, AZ 85706 US Other 510(k) Applications for this Company
Contact	STEVE BOLLINGER Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	BTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/1998
Decision Date	03/05/1998
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