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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K863427
Device Name CLAMPEASE FA
Applicant
Freund Medical Products
401 E. Fifth St.
Dayton,  OH  45402
Applicant Contact ROBERT K GARNER
Correspondent
Freund Medical Products
401 E. Fifth St.
Dayton,  OH  45402
Correspondent Contact ROBERT K GARNER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/04/1986
Decision Date 11/20/1986
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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