FDA 510(k) Application Details - K945117

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K945117
Device Name	Sterilizer, Steam
Applicant	PELTON & CRANE CO. P.O. BOX 7800 CHARLOTTE, NC 28241-7800 US Other 510(k) Applications for this Company
Contact	KRISTI KUNKEL Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/1994
Decision Date	02/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review