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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K863210
Device Name VELCOM-100
Applicant
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903
Applicant Contact LEWIS N HARROLD
Correspondent
Waters Instruments, Inc.
2411 Seventh St. NW
P.O. Box 6117
Rochester,  MN  55903
Correspondent Contact LEWIS N HARROLD
Regulation Number870.2100
Classification Product Code
DPW  
Date Received08/20/1986
Decision Date 11/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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