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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Spinal-Fluid Pressure, Electrically Powered
510(k) Number K926066
Device Name BION MUMPS-G ANTIBODY TEST SYSTEM
Applicant
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Applicant Contact EDWARD NOWAKOWSKI
Correspondent
Bion Ent., Ltd.
674 Busse Hwy.
Park Ridge,  IL  60068
Correspondent Contact EDWARD NOWAKOWSKI
Regulation Number880.2460
Classification Product Code
CAR  
Date Received12/01/1992
Decision Date 06/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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