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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, septostomy
510(k) Number K801031
Device Name BLADE SEPTOSTOMY CATHETER
Applicant
COOK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
COOK, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.5175
Classification Product Code
DXF  
Date Received05/01/1980
Decision Date 07/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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