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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 K170112
Device Name IMD's Lumbar Puncture Needle
Applicant
INTERNATIONAL MEDICAL DEVELOPMENT, INC.(IMD)
560 HIGHWAY 39 (PO BOX 510)
HUNTSVILLE,  UT  84317
Applicant Contact WALTER ZOHMANN
Correspondent
J.E. LINCOLN AND ASSOCIATES
PO BOX 2786
ST. GEORGE,  UT  84771
Correspondent Contact John E. Lincoln
Regulation Number868.5150
Classification Product Code
BSP  
Date Received01/12/2017
Decision Date 02/02/2018
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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