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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 K885342
Device Name GENNY DENNY IV SHIELD
Applicant
MERCURY ENTERPRISES, INC.
11300 A-49TH ST. NORTH
CLEARWATER,  FL  34622
Applicant Contact ARTHUR J WARD
Correspondent
MERCURY ENTERPRISES, INC.
11300 A-49TH ST. NORTH
CLEARWATER,  FL  34622
Correspondent Contact ARTHUR J WARD
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/28/1988
Decision Date 03/30/1989
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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