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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Finger Cot
510(k) Number K980827
Device Name LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
Applicant
Tucker & Associates
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
Tucker & Associates
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZB  
Date Received03/03/1998
Decision Date 05/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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