FDA 510(k) Application Details - K021224

Device Classification Name	Set, Anesthesia, Paracervical   More FDA Info for this Device
510(K) Number	K021224
Device Name	Set, Anesthesia, Paracervical
Applicant	WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. ORANGE, CT 06477 US Other 510(k) Applications for this Company
Contact	MICHAEL MALIS 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	04/17/2002
Decision Date	07/12/2002
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