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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 K951312
Device Name MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Applicant Contact K. M KROEHNKE
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103 -1625
Correspondent Contact K. M KROEHNKE
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/23/1995
Decision Date 05/03/1995
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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