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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 K955030
Device Name SQUARE ONE SAFETY SYRINGE
Applicant
SQUARE ONE MEDICAL, LP
1640 PIERSIDE LN.
CAMARILLO,  CA  93010 -6014
Applicant Contact JACK DILLARD
Correspondent
SQUARE ONE MEDICAL, LP
1640 PIERSIDE LN.
CAMARILLO,  CA  93010 -6014
Correspondent Contact JACK DILLARD
Regulation Number880.5860
Classification Product Code
MEG  
Date Received11/02/1995
Decision Date 12/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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