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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K931644
Device Name GERTIE MARX NEEDLE
Applicant
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
P.O. BOX 681180
528 PARK AVENUE
PARK CITY,  UT  84068
Applicant Contact WALTER ZOHMANN
Correspondent
INTL. MEDICAL-DENTAL PRODUCTS USA, INC.
P.O. BOX 681180
528 PARK AVENUE
PARK CITY,  UT  84068
Correspondent Contact WALTER ZOHMANN
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/02/1993
Decision Date 09/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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