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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K894502
Device Name AMMEL PATIENT EXAMINATION 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 Number880.6250
Classification Product Code
LYY  
Date Received07/19/1989
Decision Date 10/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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