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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 K891305
Original Applicant
B & L ENT. CO.
3425 south bascom avenue #e
campbell,  CA  95008
Original Contact meekness boen
Regulation Number880.6250
Classification Product Code
Date Received03/14/1989
Decision Date 04/26/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No