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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gauze/Sponge, Internal
510(k) Number K950404
Device Name LOCKETT MEDICAL CORP. GAUZE
Applicant
Lockett Medical Corp.
Three Richmond Sq.
Providence,  RI  02906
Applicant Contact DENISE TREACY
Correspondent
Lockett Medical Corp.
Three Richmond Sq.
Providence,  RI  02906
Correspondent Contact DENISE TREACY
Classification Product Code
EFQ  
Date Received01/31/1995
Decision Date 04/17/1995
Decision Substantially Equivalent (SESE)
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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