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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 K923003
Device Name PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
Applicant
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact RICHARD T LYKINS
Correspondent
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact RICHARD T LYKINS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/22/1992
Decision Date 04/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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