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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, adhesive, external
510(k) Number K934970
Device Name DUET
Applicant
TRULIFE LTD.
3 COOKSTOWN INDUSTRIAL ESTATE
TALLAGHT
DUBLIN 24,  IE
Applicant Contact JEAN TWOHIG
Correspondent
TRULIFE LTD.
3 COOKSTOWN INDUSTRIAL ESTATE
TALLAGHT
DUBLIN 24,  IE
Correspondent Contact JEAN TWOHIG
Regulation Number878.3750
Classification Product Code
GBJ  
Date Received10/18/1993
Decision Date 12/10/1993
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
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