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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 K902430
Device Name GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
Applicant
HERAEUS KULZER, INC.
DIAGNOSTICS DIVISION
P.O. BOX 70
ELKHART,  IN  46515
Applicant Contact M SAVOL
Correspondent
HERAEUS KULZER, INC.
DIAGNOSTICS DIVISION
P.O. BOX 70
ELKHART,  IN  46515
Correspondent Contact M SAVOL
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/31/1990
Decision Date 08/02/1990
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
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