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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medical glove, specialty
510(k) Number K982832
Device Name PROGUARD, RR-1, RR-2
Applicant
EMERSON & CO. S.R.L.
PIAZZA DELLA VITTORIA 10/12
GENOA,  IT 16121
Applicant Contact STEFANO COSTIGLTOLO
Correspondent
EMERSON & CO. S.R.L.
PIAZZA DELLA VITTORIA 10/12
GENOA,  IT 16121
Correspondent Contact STEFANO COSTIGLTOLO
Regulation Number880.6250
Classification Product Code
LZC  
Date Received08/12/1998
Decision Date 12/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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