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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K872889
Device Name ROMEO(TM) MODEL 1000
Applicant
Diva Medical Systems, Inc.
Riverplace, Suite 214
10 Second St., NE
Minneapolis,  MN  55413
Applicant Contact HOLCOMB, PHD
Correspondent
Diva Medical Systems, Inc.
Riverplace, Suite 214
10 Second St., NE
Minneapolis,  MN  55413
Correspondent Contact HOLCOMB, PHD
Regulation Number862.1345
Classification Product Code
CGA  
Date Received07/23/1987
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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