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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 K921683
Device Name PENCIL POINT SPINAL NEEDLE
Applicant
Hart Enterprises, Inc.
2131 Martindale SW
Wyoming,  MI  49509
Applicant Contact RON DEMAK
Correspondent
Hart Enterprises, Inc.
2131 Martindale SW
Wyoming,  MI  49509
Correspondent Contact RON DEMAK
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/08/1992
Decision Date 08/26/1993
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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