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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 K960467
Device Name POWDER FREE LATEX EXAMINATION GLOVE
Applicant
BIOPRO, INC.
22 DOGWOOD DR.
CHESTER,  NJ  07930
Applicant Contact MURIEL G WILLICH
Correspondent
BIOPRO, INC.
22 DOGWOOD DR.
CHESTER,  NJ  07930
Correspondent Contact MURIEL G WILLICH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/30/1996
Decision Date 05/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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