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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 K011369
FOIA Releasable 510(k) K011369
Device Name ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
Applicant
Safety Syringes, Inc.
1925 Palomar Oaks Way, #204
Carlsbad,  CA  92008
Applicant Contact THOMAS L HALL
Correspondent
Safety Syringes, Inc.
1925 Palomar Oaks Way, #204
Carlsbad,  CA  92008
Correspondent Contact THOMAS L HALL
Regulation Number880.5860
Classification Product Code
MEG  
Date Received05/04/2001
Decision Date 05/29/2001
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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