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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 K961151
Device Name SPINAL NEEDLES
Applicant
Hakko Shoji Co., Ltd.
3726 Lonsdale Ave.
Cincinnati,  OH  45227
Applicant Contact JOHN ROGERS
Correspondent
Hakko Shoji Co., Ltd.
3726 Lonsdale Ave.
Cincinnati,  OH  45227
Correspondent Contact JOHN ROGERS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/22/1996
Decision Date 03/19/1997
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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