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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 K911997
Device Name TENDERFOOT(R), MODIFICATION
Applicant
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Applicant Contact LES HEIMANN
Correspondent
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Correspondent Contact LES HEIMANN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/22/1991
Decision Date 07/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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