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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K103781
Device Name MED-LOK SAFETY NEEDLE
Applicant
Sta-Med, LLC
4932 E. Holbrook St.
Anaheim,  CA  92807
Applicant Contact RANDALL MAY
Correspondent
Sta-Med, LLC
4932 E. Holbrook St.
Anaheim,  CA  92807
Correspondent Contact RANDALL MAY
Regulation Number880.5860
Classification Product Code
MEG  
Date Received12/27/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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