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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 K810075
Device Name AUTOCLIX
Applicant
Biodynamics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biodynamics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4850
Classification Product Code
FMK  
Date Received01/13/1981
Decision Date 02/04/1981
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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