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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 K950133
Device Name HYPODERMIC SYRINGE PISTON
Applicant
Ispg, Inc.
517 Litchfield Rd.
New Milford,  CT  06776
Applicant Contact LORETTA F LUHMAN
Correspondent
Ispg, Inc.
517 Litchfield Rd.
New Milford,  CT  06776
Correspondent Contact LORETTA F LUHMAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/13/1995
Decision Date 04/13/1995
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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