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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 K902700
Device Name HEVEASHIELD EXAMINATION GLOVES
Applicant
Pacificlink Export
28/A Zia Apts. 264
Belasis Rd.
Bombay-400 008,  IN
Applicant Contact PAGARKAR
Correspondent
Pacificlink Export
28/A Zia Apts. 264
Belasis Rd.
Bombay-400 008,  IN
Correspondent Contact PAGARKAR
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/20/1990
Decision Date 11/02/1990
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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