FDA 510(k) Application Details - K955658

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K955658
Device Name	Wrap, Sterilization
Applicant	TRANSIDYNE GENERAL CORP. 400 HERALD JOURNAL PARK SPARTANBURG, SC 29303 US Other 510(k) Applications for this Company
Contact	STEVEN W BUTLER Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1995
Decision Date	01/25/1996
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