FDA 510(k) Application Details - K000340

Device Classification Name	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)   More FDA Info for this Device
510(K) Number	K000340
Device Name	Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Applicant	ROCKET MEDICAL PLC WEAR IND. ESTATE DISTRICT 6 WASHINGTON, TYNE & WEAR NE37 1NE GB Other 510(k) Applications for this Company
Contact	L. TODD Other 510(k) Applications for this Contact
Regulation Number	884.1300   More FDA Info for this Regulation Number
Classification Product Code	HES Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2000
Decision Date	04/19/2000
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