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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 K883736
Device Name STERILE SURGEONS GLOVES
Applicant
Medical Manufacturers Marketing Co.
15689 Chemical Ln.
Huntington Beach,  CA  92649
Applicant Contact RONALD R PATTERSON
Correspondent
Medical Manufacturers Marketing Co.
15689 Chemical Ln.
Huntington Beach,  CA  92649
Correspondent Contact RONALD R PATTERSON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/01/1988
Decision Date 10/12/1988
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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