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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 K954718
Device Name ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
Applicant
ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
ELLMAN INTL., INC.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number884.5100
Classification Product Code
HEE  
Date Received10/13/1995
Decision Date 02/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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