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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 K904662
Device Name SRI JOHANI LATEX SURGEONS GLOVES
Applicant
Transcorp
40 Dogwood Dr.
Chester,  NJ  07930
Applicant Contact S KENNEDY
Correspondent
Transcorp
40 Dogwood Dr.
Chester,  NJ  07930
Correspondent Contact S KENNEDY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/15/1990
Decision Date 01/11/1991
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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