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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K041080
Device Name SURGICAL DRAPE KIT - D.I.R.R.A. SRL
Applicant
D.I.R.R.A. S.R.L.
26, Via Guido Rossa
(Z.I. Gerbolina)
Viadana, Mantova,  IT I - 46019
Applicant Contact ELISABETTA BACCHI
Correspondent
D.I.R.R.A. S.R.L.
26, Via Guido Rossa
(Z.I. Gerbolina)
Viadana, Mantova,  IT I - 46019
Correspondent Contact ELISABETTA BACCHI
Regulation Number878.4370
Classification Product Code
LRO  
Date Received04/26/2004
Decision Date 11/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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