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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K955514
Device Name SHARPS SAFE 1.5 & SHARPS SAFE 2.0
Applicant
Dura-Vac Products
4464 Mcgrath St., #114
Ventura,  CA  93003
Applicant Contact NEAL SHULTS
Correspondent
Dura-Vac Products
4464 Mcgrath St., #114
Ventura,  CA  93003
Correspondent Contact NEAL SHULTS
Regulation Number880.5570
Classification Product Code
MMK  
Date Received12/04/1995
Decision Date 08/01/1996
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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