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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K023108
Device Name STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
Applicant
Atlantic Products, Inc.
24 Center St.
Hicksville,  NY  11801
Applicant Contact MAHBUBUR RAHMAN
Correspondent
Atlantic Products, Inc.
24 Center St.
Hicksville,  NY  11801
Correspondent Contact MAHBUBUR RAHMAN
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received09/18/2002
Decision Date 12/03/2002
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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