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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K000329
Device Name NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
Applicant
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Applicant Contact JOY LANCASTER
Correspondent
Siam Sempermed Corp., Ltd.
30798 Us Hwy. 19n
Palm Harbor,  FL  34684
Correspondent Contact JOY LANCASTER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received02/02/2000
Decision Date 04/05/2000
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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