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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 K032981
Device Name SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
Applicant
INVAMED TECHNOLOGIES INC.
9955 TITAN PARK CIRCLE
LITTLETON,  CO  80125
Applicant Contact TIM DUVALL
Correspondent
INVAMED TECHNOLOGIES INC.
9955 TITAN PARK CIRCLE
LITTLETON,  CO  80125
Correspondent Contact TIM DUVALL
Regulation Number868.5150
Classification Product Code
BSP  
Date Received09/24/2003
Decision Date 04/22/2004
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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