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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 K980238
Device Name GYNEX EXTENDED REACH NEEDLE
Applicant
GYNEX CORP.
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
GYNEX CORP.
1000 BURNETT AVE.
SUITE 450
CONCORD,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number884.5100
Classification Product Code
HEE  
Date Received01/23/1998
Decision Date 08/21/1998
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
Predetermined Change
Control Plan Authorized		 No
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