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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, anesthesia, paracervical
510(k) Number K021224
Device Name ENDOCERVICAL BLOCK NEEDLE
Applicant
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE,  CT  06477
Applicant Contact MICHAEL MALIS
Correspondent
WALLACH SURGICAL DEVICES, INC.
235 EDISON RD.
ORANGE,  CT  06477
Correspondent Contact MICHAEL MALIS
Regulation Number884.5100
Classification Product Code
HEE  
Date Received04/17/2002
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
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