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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 K022495
Device Name GETTIG DISPOSABLE SYRINGES
Applicant
Gettig Pharmaceutical Instrument Co.
One Streamside Pl. W.
Spring Mills,  PA  16875
Applicant Contact JAMES A BENZ
Correspondent
Gettig Pharmaceutical Instrument Co.
One Streamside Pl. W.
Spring Mills,  PA  16875
Correspondent Contact JAMES A BENZ
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/29/2002
Decision Date 10/08/2002
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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