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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 K920700
Device Name SEAMLESS LATEX PATIENT EXAM GLOVES
Applicant
Digitcare Corp.
300 S. Beverly Dr.
Beverly Hils,  CA  90212
Applicant Contact MICHAEL WOOL
Correspondent
Digitcare Corp.
300 S. Beverly Dr.
Beverly Hils,  CA  90212
Correspondent Contact MICHAEL WOOL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/11/1992
Decision Date 05/11/1992
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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