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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 K853549
Device Name MCGAW/DROP WATCH FLOW MONITOR
Applicant
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Applicant Contact JOYCE WILLIAMS
Correspondent
American Mcgaw
P.O. Box 1187
Santa Ana,  CA  92711
Correspondent Contact JOYCE WILLIAMS
Regulation Number880.2420
Classification Product Code
FLN  
Date Received08/26/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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