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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 K933365
Device Name BABISTICK
Applicant
Graphic Controls Corp.
189 Van Rensselaer St.
Buffalo,  NY  14240
Applicant Contact JOHN H BARRETT
Correspondent
Graphic Controls Corp.
189 Van Rensselaer St.
Buffalo,  NY  14240
Correspondent Contact JOHN H BARRETT
Regulation Number878.4850
Classification Product Code
FMK  
Subsequent Product Code
JCA  
Date Received07/09/1993
Decision Date 10/19/1993
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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