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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 K951513
Device Name JAI
Applicant
Intl. Trade Management Co.
11321 Headlands Court
Reston,  VA  22091
Applicant Contact MEHUL RANDERY
Correspondent
Intl. Trade Management Co.
11321 Headlands Court
Reston,  VA  22091
Correspondent Contact MEHUL RANDERY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/03/1995
Decision Date 05/25/1995
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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