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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K942548
Device Name JENNINGS JAVELIN
Applicant
Jfi Endineering, Inc.
380 Clinton St.
Costa Mesa,  CA  92626
Applicant Contact STEPHEN J COONAN
Correspondent
Jfi Endineering, Inc.
380 Clinton St.
Costa Mesa,  CA  92626
Correspondent Contact STEPHEN J COONAN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/31/1994
Decision Date 11/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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