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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. Srl
Piazza Della Vittoria 10/12
Genoa,  IT 16121
Applicant Contact STEFANO COSTIGLTOLO
Correspondent
Emerson & Co. Srl
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 General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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