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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 K983897
Device Name CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
Applicant
RI MOS. S.R.L.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Applicant Contact ADENA S RIEMER
Correspondent
RI MOS. S.R.L.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Correspondent Contact ADENA S RIEMER
Regulation Number884.5100
Classification Product Code
HEE  
Date Received11/03/1998
Decision Date 02/01/1999
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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