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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 K950622
Device Name MEGA MEDITEX LIMITED
Applicant
Mega Meditex , Ltd.
Mittal Tower, 'B' Wing,
16th Floor, 210, Nariman Pt.
Bombay 400 021,  IN 400 021
Applicant Contact AJAY MITTAL
Correspondent
Mega Meditex , Ltd.
Mittal Tower, 'B' Wing,
16th Floor, 210, Nariman Pt.
Bombay 400 021,  IN 400 021
Correspondent Contact AJAY MITTAL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received02/10/1995
Decision Date 06/02/1995
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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