FDA 510(k) Application Details - K052365

Device Classification Name	Set, Anesthesia, Paracervical   More FDA Info for this Device
510(K) Number	K052365
Device Name	Set, Anesthesia, Paracervical
Applicant	ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE WASHINGTON TYNE AND WEAR NE38 9BZ GB Other 510(k) Applications for this Company
Contact	TRACY CHARLTON Other 510(k) Applications for this Contact
Regulation Number	884.5100   More FDA Info for this Regulation Number
Classification Product Code	HEE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2005
Decision Date	10/17/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review