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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 K896944
Device Name CN CARE STERILE LATEX EXAMINATION GLOVES
Applicant
C.N. Technocrats
108-13, 65th Rd.
Forest Hills,  NY  11375
Applicant Contact SANKAR NAIR
Correspondent
C.N. Technocrats
108-13, 65th Rd.
Forest Hills,  NY  11375
Correspondent Contact SANKAR NAIR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received12/13/1989
Decision Date 01/10/1990
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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