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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K030136
Device Name DRIP ALERT
Applicant
Drip Alert, Inc.
500 E. Broward Blvd.
Suite 1400
Ft. Lauderdale,  FL  33394
Applicant Contact POLLY D HESEMAN
Correspondent
Drip Alert, Inc.
500 E. Broward Blvd.
Suite 1400
Ft. Lauderdale,  FL  33394
Correspondent Contact POLLY D HESEMAN
Regulation Number880.2420
Classification Product Code
FLN  
Date Received01/14/2003
Decision Date 04/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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