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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 K833344
Device Name AUTO-LANCET
Applicant
Palco Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Palco Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/27/1983
Decision Date 11/07/1983
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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