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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K890344
Device Name GLOVES, PATIENT EXAMINATION
Applicant
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Applicant Contact FOO
Correspondent
Tomarc (M) Sdn Bhd
5, Lorong Helang Hindik
Kepong Baru Industrial Estate
Kuala Lumpar,  MY 52100
Correspondent Contact FOO
Regulation Number866.1620
Classification Product Code
JTN  
Date Received01/23/1989
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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