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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K882001
Device Name DIACARE MONITORING SYSTEM
Applicant
Healthware Corp.
1713 Cole Mill Rd.
Durham,  NC  27712
Applicant Contact S SURWIT,PHD
Correspondent
Healthware Corp.
1713 Cole Mill Rd.
Durham,  NC  27712
Correspondent Contact S SURWIT,PHD
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/12/1988
Decision Date 10/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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