FDA 510(k) Application Details - K955790

Device Classification Name	Speculum, Vaginal, Nonmetal, Fiberoptic   More FDA Info for this Device
510(K) Number	K955790
Device Name	Speculum, Vaginal, Nonmetal, Fiberoptic
Applicant	TRYLON CORP. 23268 ATLANTIS WAY MONARCH BEACH, CA 92629 US Other 510(k) Applications for this Company
Contact	A. THOMAS DOYLE Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1995
Decision Date	03/21/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review