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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K050434
Device Name SHL DISPOSABLE AUTOINJECTOR
Applicant
Shl Medical, USA
23 Vreeland Rd.,
Suite 104
Florham Park,  NJ  07932
Applicant Contact LUCIO GIAMBATTISTA
Correspondent
Shl Medical, USA
23 Vreeland Rd.,
Suite 104
Florham Park,  NJ  07932
Correspondent Contact LUCIO GIAMBATTISTA
Regulation Number880.6920
Classification Product Code
KZH  
Date Received02/22/2005
Decision Date 06/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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