ENDOCERVICAL BLOCK NEEDLE


Device Classification Name

set, anesthesia, paracervical

510(k) Number K021224
Device Name ENDOCERVICAL BLOCK NEEDLE
Original Applicant
WALLACH SURGICAL DEVICES, INC.
235 edison rd.
orange, 
CT 
06477

Original Contact michael malis
Regulation Number 884.5100
Classification Product Code
HEE  
Date Received 04/17/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No