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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 K070354
Device Name IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT)
Applicant
INTERNATIONAL MEDICAL DEVELOPMENT, INC
9202 KELLEY DRIVE
P.O. BOX 510
HUNTSVILLE,  UT  84317
Applicant Contact WALTER ZOHMANN
Correspondent
INTERNATIONAL MEDICAL DEVELOPMENT, INC
9202 KELLEY DRIVE
P.O. BOX 510
HUNTSVILLE,  UT  84317
Correspondent Contact WALTER ZOHMANN
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/06/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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