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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 K991758
Device Name MONOJECT INSULIN SYRINGE
Applicant
The Kendal Co.
15 Hampshire St.
Mansfield,  MA  02048 -1108
Applicant Contact FRANK J FUCILE
Correspondent
The Kendal Co.
15 Hampshire St.
Mansfield,  MA  02048 -1108
Correspondent Contact FRANK J FUCILE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/24/1999
Decision Date 06/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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