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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K920761
Device Name URINE CULTUR STABILIZATION TRANSPORT TUBE
Applicant
Bio Medicus, Inc.
50 White Meadow Rd.
Rockaway,  NJ  07866
Applicant Contact GEPPERT SR.
Correspondent
Bio Medicus, Inc.
50 White Meadow Rd.
Rockaway,  NJ  07866
Correspondent Contact GEPPERT SR.
Regulation Number866.2900
Classification Product Code
LIO  
Date Received02/19/1992
Decision Date 06/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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