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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K894501
Device Name AMMEL STERILE SURGEON'S GLOVES
Applicant
Mauricio Menconi
Berduc 2044 Y Roma
(1686) Hurlingham-Pcia-Bs: As:
Argentina,  AR
Applicant Contact MAURICIO MENCONI
Correspondent
Mauricio Menconi
Berduc 2044 Y Roma
(1686) Hurlingham-Pcia-Bs: As:
Argentina,  AR
Correspondent Contact MAURICIO MENCONI
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/19/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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